Prostate Cancer

Newly released figures showing a rise in the number of men with advanced prostate cancer have laid bare long-simmering resentment among patient advocates who feel the nation’s leading cancer group has largely ignored their concerns for years.

The American Cancer Society on Jan. 13 revealed what it called “alarming” news about prostate cancer: After 2 decades of decline, the number of men diagnosed with the disease in the United States rose by 15% from 2014 to 2019.

“Most concerning,” according to the group’s CEO Karen Knudsen, PhD, MBA, is that the increase is being driven by diagnoses of advanced disease.

“Since 2011, the diagnosis of advanced-stage (regional- or distant-stage) prostate cancer has increased by 4%-5% annually and the proportion of men diagnosed with distant-stage disease has doubled,” said Dr. Knudsen at a press conference concerning the figures. “These findings underscore the importance of understanding and reducing this trend.”

The increase, which works out to be an additional 99,000 cases of prostate cancer, did not take the ACS by surprise; the group has been predicting a jump in diagnoses of the disease, which is the most common cancer in men after skin cancer, and the second most common cause of cancer death for that group.

The ACS announced a new action plan, “Improving Mortality from Prostate Cancer Together” – or IMPACT – to address the rise, especially in Black men, and to curb the increasing rate of advanced, difficult-to-treat cases.

“We must address these shifts in prostate cancer, especially in the Black community, since the incidence of prostate cancer in Black men is 70% higher than in White men and prostate cancer mortality rates in Black men are approximately two to four times higher than those in every other racial and ethnic group,” William Dahut, MD, PhD, chief scientific officer for the ACS, said at the press conference.

A study published in JAMA Network Open challenged that claim, finding that, after controlling for socioeconomic factors, race does not appear to be a significant predictor of mortality for prostate cancer.

Dr. Dahut said in an interview that IMPACT “is still [in the] early days for this initiative and more details will be coming out soon.”

Charles Ryan, MD, CEO of the Prostate Cancer Foundation, the world’s largest prostate cancer research charity, called IMPACT “extremely important work. Highlighting the disparities can only serve to benefit all men with prostate cancer, especially Black men.”
 

Bold action ... or passivity?

Overall cancer mortality has dropped 33% since 1991, averting an estimated 3.8 million deaths, according to ACS. But the story for prostate cancer is different.

The society and advocates had warned as recently as 2 years ago that prostate cancer was poised to rise again, especially advanced cases that may be too late to treat.

Leaders in the prostate cancer advocacy community praised the ACS plan for IMPACT, but some expressed frustration over what they said was ACS’ passivity in the face of long-anticipated increases in cases of the disease.

“I think prostate cancer was not high on their agenda,” said Rick Davis, founder of AnCan, which offers several support groups for patients with prostate cancer.  “It’s good to see ACS get back into the prostate cancer game.”

Mr. Davis and patient advocate Darryl Mitteldorf, LCSW, founder of Malecare, another prostate support organization, said ACS dropped patient services for prostate cancer patients a decade ago and has not been a vocal supporter of screening for levels of prostate-specific antigen (PSA) to detect prostate cancer early.

“Early detection is supposed to be their goal,” Mr. Davis said.

In 2012, the U.S. Preventive Services Task Force recommended against PSA screening, giving it a D-rating. The move prompted attacks on the task force from most advocates and many urologists.

Following this criticism, the task force recommended shared decision-making between patient and doctor, while giving PSA screening a C-rating. Now, the ACS recommends men in general at age 50 discuss prostate cancer screening with their doctor and that Black men do the same at age 45.

Mr. Mitteldorf said ACS “owes prostate cancer patients an explanation and analysis of its response to the USPTF’s downgrade of PSA testing and how that response might be related to death and instance rates.”

Mr. Mitteldorf added that male patients lost key support from ACS when the group dismantled its Man to Man group for prostate cancer patients and its Brother to Brother group for Blacks in particular.

Dr. Dahut said Man to Man “sunsetted” and was turned over to any local organization that chose to offer it. He said longtime staff didn’t have “a lot of information about [the demise of] Brother to Brother.”

For Mr. Davis, those smaller cuts add up to a much larger insult.

“Today, in 2023, ACS continues to poke a finger in the eyes of prostate cancer patients,” he said. “Since 2010, they have not given us any respect. ACS dumped its support.”

He pointed to the group’s funding priorities, noting that outlays for prostate cancer have consistently lagged behind those for breast cancer.

The ACS spent $25.3 million on breast cancer research and $6.7 million for prostate cancer in 2018, and in 2023 will designate $126.5 for breast cancer research and $43.9 million for prostate cancer.

ACS has earmarked $62 million this year for lung cancer programs and $61 million for colorectal cancer.

“Parity between breast cancer and prostate cancer would be a good start in sizing the IMPACT program,” Mr. Davis said. “After all, breast cancer and prostate cancer are hardly different in numbers today.”

Dr. Dahut denied any gender bias in research funding. He said the group makes funding decisions “based on finding the most impactful science regardless of tumor type. Our mission includes funding every cancer, every day; thus, we generally do not go into our funding cycle with any set-asides for a particular cancer.”

Mr. Davis also said the ACS data suggest the growing number of prostate cancer cases is even worse than the group has said. Although the society cites a 3% annual increase in prostate cancer diagnoses from 2014 to 2019, since 2019 the annual increase is a much more dramatic 16%. Meanwhile, the number of new cases of the disease is projected to rise from 175,000 per year in 2019 to 288,000 this year.

Dr. Dahut said the society used the 2014-2019 time frame for technical reasons, separating confirmed cases in the earlier period from estimated cases in recent years.

“We discourage comparing projected cases over time because these cases are model-based and subject to fluctuations,” Dr. Dahut said.

A version of this article originally appeared on Medscape.com.

Newly released figures showing a rise in the number of men with advanced prostate cancer have laid bare long-simmering resentment among patient advocates who feel the nation’s leading cancer group has largely ignored their concerns for years.

The American Cancer Society on Jan. 13 revealed what it called “alarming” news about prostate cancer: After 2 decades of decline, the number of men diagnosed with the disease in the United States rose by 15% from 2014 to 2019.

“Most concerning,” according to the group’s CEO Karen Knudsen, PhD, MBA, is that the increase is being driven by diagnoses of advanced disease.

“Since 2011, the diagnosis of advanced-stage (regional- or distant-stage) prostate cancer has increased by 4%-5% annually and the proportion of men diagnosed with distant-stage disease has doubled,” said Dr. Knudsen at a press conference concerning the figures. “These findings underscore the importance of understanding and reducing this trend.”

The increase, which works out to be an additional 99,000 cases of prostate cancer, did not take the ACS by surprise; the group has been predicting a jump in diagnoses of the disease, which is the most common cancer in men after skin cancer, and the second most common cause of cancer death for that group.

The ACS announced a new action plan, “Improving Mortality from Prostate Cancer Together” – or IMPACT – to address the rise, especially in Black men, and to curb the increasing rate of advanced, difficult-to-treat cases.

“We must address these shifts in prostate cancer, especially in the Black community, since the incidence of prostate cancer in Black men is 70% higher than in White men and prostate cancer mortality rates in Black men are approximately two to four times higher than those in every other racial and ethnic group,” William Dahut, MD, PhD, chief scientific officer for the ACS, said at the press conference.

A study published in JAMA Network Open challenged that claim, finding that, after controlling for socioeconomic factors, race does not appear to be a significant predictor of mortality for prostate cancer.

Dr. Dahut said in an interview that IMPACT “is still [in the] early days for this initiative and more details will be coming out soon.”

Charles Ryan, MD, CEO of the Prostate Cancer Foundation, the world’s largest prostate cancer research charity, called IMPACT “extremely important work. Highlighting the disparities can only serve to benefit all men with prostate cancer, especially Black men.”
 

Bold action ... or passivity?

Overall cancer mortality has dropped 33% since 1991, averting an estimated 3.8 million deaths, according to ACS. But the story for prostate cancer is different.

The society and advocates had warned as recently as 2 years ago that prostate cancer was poised to rise again, especially advanced cases that may be too late to treat.

Leaders in the prostate cancer advocacy community praised the ACS plan for IMPACT, but some expressed frustration over what they said was ACS’ passivity in the face of long-anticipated increases in cases of the disease.

“I think prostate cancer was not high on their agenda,” said Rick Davis, founder of AnCan, which offers several support groups for patients with prostate cancer.  “It’s good to see ACS get back into the prostate cancer game.”

Mr. Davis and patient advocate Darryl Mitteldorf, LCSW, founder of Malecare, another prostate support organization, said ACS dropped patient services for prostate cancer patients a decade ago and has not been a vocal supporter of screening for levels of prostate-specific antigen (PSA) to detect prostate cancer early.

“Early detection is supposed to be their goal,” Mr. Davis said.

In 2012, the U.S. Preventive Services Task Force recommended against PSA screening, giving it a D-rating. The move prompted attacks on the task force from most advocates and many urologists.

Following this criticism, the task force recommended shared decision-making between patient and doctor, while giving PSA screening a C-rating. Now, the ACS recommends men in general at age 50 discuss prostate cancer screening with their doctor and that Black men do the same at age 45.

Mr. Mitteldorf said ACS “owes prostate cancer patients an explanation and analysis of its response to the USPTF’s downgrade of PSA testing and how that response might be related to death and instance rates.”

Mr. Mitteldorf added that male patients lost key support from ACS when the group dismantled its Man to Man group for prostate cancer patients and its Brother to Brother group for Blacks in particular.

Dr. Dahut said Man to Man “sunsetted” and was turned over to any local organization that chose to offer it. He said longtime staff didn’t have “a lot of information about [the demise of] Brother to Brother.”

For Mr. Davis, those smaller cuts add up to a much larger insult.

“Today, in 2023, ACS continues to poke a finger in the eyes of prostate cancer patients,” he said. “Since 2010, they have not given us any respect. ACS dumped its support.”

He pointed to the group’s funding priorities, noting that outlays for prostate cancer have consistently lagged behind those for breast cancer.

The ACS spent $25.3 million on breast cancer research and $6.7 million for prostate cancer in 2018, and in 2023 will designate $126.5 for breast cancer research and $43.9 million for prostate cancer.

ACS has earmarked $62 million this year for lung cancer programs and $61 million for colorectal cancer.

“Parity between breast cancer and prostate cancer would be a good start in sizing the IMPACT program,” Mr. Davis said. “After all, breast cancer and prostate cancer are hardly different in numbers today.”

Dr. Dahut denied any gender bias in research funding. He said the group makes funding decisions “based on finding the most impactful science regardless of tumor type. Our mission includes funding every cancer, every day; thus, we generally do not go into our funding cycle with any set-asides for a particular cancer.”

Mr. Davis also said the ACS data suggest the growing number of prostate cancer cases is even worse than the group has said. Although the society cites a 3% annual increase in prostate cancer diagnoses from 2014 to 2019, since 2019 the annual increase is a much more dramatic 16%. Meanwhile, the number of new cases of the disease is projected to rise from 175,000 per year in 2019 to 288,000 this year.

Dr. Dahut said the society used the 2014-2019 time frame for technical reasons, separating confirmed cases in the earlier period from estimated cases in recent years.

“We discourage comparing projected cases over time because these cases are model-based and subject to fluctuations,” Dr. Dahut said.

A version of this article originally appeared on Medscape.com.

Newly released figures showing a rise in the number of men with advanced prostate cancer have laid bare long-simmering resentment among patient advocates who feel the nation’s leading cancer group has largely ignored their concerns for years.

The American Cancer Society on Jan. 13 revealed what it called “alarming” news about prostate cancer: After 2 decades of decline, the number of men diagnosed with the disease in the United States rose by 15% from 2014 to 2019.

“Most concerning,” according to the group’s CEO Karen Knudsen, PhD, MBA, is that the increase is being driven by diagnoses of advanced disease.

“Since 2011, the diagnosis of advanced-stage (regional- or distant-stage) prostate cancer has increased by 4%-5% annually and the proportion of men diagnosed with distant-stage disease has doubled,” said Dr. Knudsen at a press conference concerning the figures. “These findings underscore the importance of understanding and reducing this trend.”

The increase, which works out to be an additional 99,000 cases of prostate cancer, did not take the ACS by surprise; the group has been predicting a jump in diagnoses of the disease, which is the most common cancer in men after skin cancer, and the second most common cause of cancer death for that group.

The ACS announced a new action plan, “Improving Mortality from Prostate Cancer Together” – or IMPACT – to address the rise, especially in Black men, and to curb the increasing rate of advanced, difficult-to-treat cases.

“We must address these shifts in prostate cancer, especially in the Black community, since the incidence of prostate cancer in Black men is 70% higher than in White men and prostate cancer mortality rates in Black men are approximately two to four times higher than those in every other racial and ethnic group,” William Dahut, MD, PhD, chief scientific officer for the ACS, said at the press conference.

A study published in JAMA Network Open challenged that claim, finding that, after controlling for socioeconomic factors, race does not appear to be a significant predictor of mortality for prostate cancer.

Dr. Dahut said in an interview that IMPACT “is still [in the] early days for this initiative and more details will be coming out soon.”

Charles Ryan, MD, CEO of the Prostate Cancer Foundation, the world’s largest prostate cancer research charity, called IMPACT “extremely important work. Highlighting the disparities can only serve to benefit all men with prostate cancer, especially Black men.”
 

Bold action ... or passivity?

Overall cancer mortality has dropped 33% since 1991, averting an estimated 3.8 million deaths, according to ACS. But the story for prostate cancer is different.

The society and advocates had warned as recently as 2 years ago that prostate cancer was poised to rise again, especially advanced cases that may be too late to treat.

Leaders in the prostate cancer advocacy community praised the ACS plan for IMPACT, but some expressed frustration over what they said was ACS’ passivity in the face of long-anticipated increases in cases of the disease.

“I think prostate cancer was not high on their agenda,” said Rick Davis, founder of AnCan, which offers several support groups for patients with prostate cancer.  “It’s good to see ACS get back into the prostate cancer game.”

Mr. Davis and patient advocate Darryl Mitteldorf, LCSW, founder of Malecare, another prostate support organization, said ACS dropped patient services for prostate cancer patients a decade ago and has not been a vocal supporter of screening for levels of prostate-specific antigen (PSA) to detect prostate cancer early.

“Early detection is supposed to be their goal,” Mr. Davis said.

In 2012, the U.S. Preventive Services Task Force recommended against PSA screening, giving it a D-rating. The move prompted attacks on the task force from most advocates and many urologists.

Following this criticism, the task force recommended shared decision-making between patient and doctor, while giving PSA screening a C-rating. Now, the ACS recommends men in general at age 50 discuss prostate cancer screening with their doctor and that Black men do the same at age 45.

Mr. Mitteldorf said ACS “owes prostate cancer patients an explanation and analysis of its response to the USPTF’s downgrade of PSA testing and how that response might be related to death and instance rates.”

Mr. Mitteldorf added that male patients lost key support from ACS when the group dismantled its Man to Man group for prostate cancer patients and its Brother to Brother group for Blacks in particular.

Dr. Dahut said Man to Man “sunsetted” and was turned over to any local organization that chose to offer it. He said longtime staff didn’t have “a lot of information about [the demise of] Brother to Brother.”

For Mr. Davis, those smaller cuts add up to a much larger insult.

“Today, in 2023, ACS continues to poke a finger in the eyes of prostate cancer patients,” he said. “Since 2010, they have not given us any respect. ACS dumped its support.”

He pointed to the group’s funding priorities, noting that outlays for prostate cancer have consistently lagged behind those for breast cancer.

The ACS spent $25.3 million on breast cancer research and $6.7 million for prostate cancer in 2018, and in 2023 will designate $126.5 for breast cancer research and $43.9 million for prostate cancer.

ACS has earmarked $62 million this year for lung cancer programs and $61 million for colorectal cancer.

“Parity between breast cancer and prostate cancer would be a good start in sizing the IMPACT program,” Mr. Davis said. “After all, breast cancer and prostate cancer are hardly different in numbers today.”

Dr. Dahut denied any gender bias in research funding. He said the group makes funding decisions “based on finding the most impactful science regardless of tumor type. Our mission includes funding every cancer, every day; thus, we generally do not go into our funding cycle with any set-asides for a particular cancer.”

Mr. Davis also said the ACS data suggest the growing number of prostate cancer cases is even worse than the group has said. Although the society cites a 3% annual increase in prostate cancer diagnoses from 2014 to 2019, since 2019 the annual increase is a much more dramatic 16%. Meanwhile, the number of new cases of the disease is projected to rise from 175,000 per year in 2019 to 288,000 this year.

Dr. Dahut said the society used the 2014-2019 time frame for technical reasons, separating confirmed cases in the earlier period from estimated cases in recent years.

“We discourage comparing projected cases over time because these cases are model-based and subject to fluctuations,” Dr. Dahut said.

A version of this article originally appeared on Medscape.com.

Current guidelines recommend against screening for prostate cancer in men who are 70 years old and older, as it is considered to be “low value” with little or no benefit for the individual. Yet a new study shows that testing for prostate-specific antigen (PSA) and also digital rectal examinations (DRE) are both carried out frequently in older men, even when there is no indication for such testing.

“As a man ages, the risk for a false-positive result increases,” said lead author Chris Gillette, PhD, associate professor of physician assistant studies at Wake Forest University, Winston-Salem, N.C., in a statement

The study authors looked at primary care visits for men who were age 70 or older, and found that, per 100 visits, there were 6.7 PSA tests and 1.6 DRE performed.

Dr. Gillette and colleagues emphasized the importance of their findings. Whereas prior studies have relied on commercially insured men or patient-reported rates of PSA testing, they used a nationally representative clinical dataset that is much more inclusive, as it includes men who are also uninsured or insured through traditional Medicare.

The study was published online in the Journal of the American Board of Family Medicine.

Screening for prostate cancer has been much debated, and the guidelines have changed in recent years. In the period 2012-2018, the U.S. Preventive Services Task Force recommended against PSA-based screening in all men, but then the guidelines changed, and the USPSTF subsequently endorsed individualized screening in those aged 55-69 years after a shared decision-making discussion. That same 2018 update also recommends against PSA screening in men over the age of 70.

In addition, the American Urological Association has recommended against PSA-based prostate cancer screening for men over the age of 70 since 2013.

Previous studies have shown that clinicians are not adhering to the guidelines. An analysis conducted in March 2022 found that about one in four accredited U.S. cancer centers fails to follow national guidelines for PSA testing to screen for prostate cancer. Contrary to national guidelines, which advocate shared decision-making, 22% of centers recommend all men universally initiate PSA screening at either age 50 or 55 and another 4% of centers recommend this before age 50, earlier than the guidelines advise.

In the current study, Dr. Gillette and colleagues conducted a secondary analysis of the National Ambulatory Medical Care Survey datasets from 2013 to 2016 and 2018. The dataset is a nationally representative sample of visits to nonfederal, office-based physician clinics. This analysis was restricted to male patients aged 70 years and older who visited a primary care clinic.

The team found that health care professionals who order a lot of tests are more likely to order low-value screening such as PSA and DRE.

The data also showed that when there were a higher number of services ordered/provided, the patients were significantly more likely to receive a low-value PSA (odds ratio, 1.49) and a low-value DRE (OR, 1.37). In contrast, patients who had more previous visits to the clinician were less likely to receive a low-value DRE (OR, 0.92).

Overall, there a decline in low-value PSA screening after 2014, but this trend was not seen for DRE during primary care visits.

Speculating as to why these low-value tests are being carried out, Dr. Gillette suggested that health care professionals might be responding to patient requests when ordering these screening tests, or they may be using what’s known as a “shotgun” approach to medical testing where all possible tests are ordered during a medical visit.

“However, as health care systems move toward a more value-based care system – where the benefit of services provided outweighs any risks – clinicians need to engage patients in these discussions on the complexity of this testing,” he commented. “Ultimately, when and if to screen is a decision best left between a provider and the patient.”

There was no outside funding and the authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Current guidelines recommend against screening for prostate cancer in men who are 70 years old and older, as it is considered to be “low value” with little or no benefit for the individual. Yet a new study shows that testing for prostate-specific antigen (PSA) and also digital rectal examinations (DRE) are both carried out frequently in older men, even when there is no indication for such testing.

“As a man ages, the risk for a false-positive result increases,” said lead author Chris Gillette, PhD, associate professor of physician assistant studies at Wake Forest University, Winston-Salem, N.C., in a statement

The study authors looked at primary care visits for men who were age 70 or older, and found that, per 100 visits, there were 6.7 PSA tests and 1.6 DRE performed.

Dr. Gillette and colleagues emphasized the importance of their findings. Whereas prior studies have relied on commercially insured men or patient-reported rates of PSA testing, they used a nationally representative clinical dataset that is much more inclusive, as it includes men who are also uninsured or insured through traditional Medicare.

The study was published online in the Journal of the American Board of Family Medicine.

Screening for prostate cancer has been much debated, and the guidelines have changed in recent years. In the period 2012-2018, the U.S. Preventive Services Task Force recommended against PSA-based screening in all men, but then the guidelines changed, and the USPSTF subsequently endorsed individualized screening in those aged 55-69 years after a shared decision-making discussion. That same 2018 update also recommends against PSA screening in men over the age of 70.

In addition, the American Urological Association has recommended against PSA-based prostate cancer screening for men over the age of 70 since 2013.

Previous studies have shown that clinicians are not adhering to the guidelines. An analysis conducted in March 2022 found that about one in four accredited U.S. cancer centers fails to follow national guidelines for PSA testing to screen for prostate cancer. Contrary to national guidelines, which advocate shared decision-making, 22% of centers recommend all men universally initiate PSA screening at either age 50 or 55 and another 4% of centers recommend this before age 50, earlier than the guidelines advise.

In the current study, Dr. Gillette and colleagues conducted a secondary analysis of the National Ambulatory Medical Care Survey datasets from 2013 to 2016 and 2018. The dataset is a nationally representative sample of visits to nonfederal, office-based physician clinics. This analysis was restricted to male patients aged 70 years and older who visited a primary care clinic.

The team found that health care professionals who order a lot of tests are more likely to order low-value screening such as PSA and DRE.

The data also showed that when there were a higher number of services ordered/provided, the patients were significantly more likely to receive a low-value PSA (odds ratio, 1.49) and a low-value DRE (OR, 1.37). In contrast, patients who had more previous visits to the clinician were less likely to receive a low-value DRE (OR, 0.92).

Overall, there a decline in low-value PSA screening after 2014, but this trend was not seen for DRE during primary care visits.

Speculating as to why these low-value tests are being carried out, Dr. Gillette suggested that health care professionals might be responding to patient requests when ordering these screening tests, or they may be using what’s known as a “shotgun” approach to medical testing where all possible tests are ordered during a medical visit.

“However, as health care systems move toward a more value-based care system – where the benefit of services provided outweighs any risks – clinicians need to engage patients in these discussions on the complexity of this testing,” he commented. “Ultimately, when and if to screen is a decision best left between a provider and the patient.”

There was no outside funding and the authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Current guidelines recommend against screening for prostate cancer in men who are 70 years old and older, as it is considered to be “low value” with little or no benefit for the individual. Yet a new study shows that testing for prostate-specific antigen (PSA) and also digital rectal examinations (DRE) are both carried out frequently in older men, even when there is no indication for such testing.

“As a man ages, the risk for a false-positive result increases,” said lead author Chris Gillette, PhD, associate professor of physician assistant studies at Wake Forest University, Winston-Salem, N.C., in a statement

The study authors looked at primary care visits for men who were age 70 or older, and found that, per 100 visits, there were 6.7 PSA tests and 1.6 DRE performed.

Dr. Gillette and colleagues emphasized the importance of their findings. Whereas prior studies have relied on commercially insured men or patient-reported rates of PSA testing, they used a nationally representative clinical dataset that is much more inclusive, as it includes men who are also uninsured or insured through traditional Medicare.

The study was published online in the Journal of the American Board of Family Medicine.

Screening for prostate cancer has been much debated, and the guidelines have changed in recent years. In the period 2012-2018, the U.S. Preventive Services Task Force recommended against PSA-based screening in all men, but then the guidelines changed, and the USPSTF subsequently endorsed individualized screening in those aged 55-69 years after a shared decision-making discussion. That same 2018 update also recommends against PSA screening in men over the age of 70.

In addition, the American Urological Association has recommended against PSA-based prostate cancer screening for men over the age of 70 since 2013.

Previous studies have shown that clinicians are not adhering to the guidelines. An analysis conducted in March 2022 found that about one in four accredited U.S. cancer centers fails to follow national guidelines for PSA testing to screen for prostate cancer. Contrary to national guidelines, which advocate shared decision-making, 22% of centers recommend all men universally initiate PSA screening at either age 50 or 55 and another 4% of centers recommend this before age 50, earlier than the guidelines advise.

In the current study, Dr. Gillette and colleagues conducted a secondary analysis of the National Ambulatory Medical Care Survey datasets from 2013 to 2016 and 2018. The dataset is a nationally representative sample of visits to nonfederal, office-based physician clinics. This analysis was restricted to male patients aged 70 years and older who visited a primary care clinic.

The team found that health care professionals who order a lot of tests are more likely to order low-value screening such as PSA and DRE.

The data also showed that when there were a higher number of services ordered/provided, the patients were significantly more likely to receive a low-value PSA (odds ratio, 1.49) and a low-value DRE (OR, 1.37). In contrast, patients who had more previous visits to the clinician were less likely to receive a low-value DRE (OR, 0.92).

Overall, there a decline in low-value PSA screening after 2014, but this trend was not seen for DRE during primary care visits.

Speculating as to why these low-value tests are being carried out, Dr. Gillette suggested that health care professionals might be responding to patient requests when ordering these screening tests, or they may be using what’s known as a “shotgun” approach to medical testing where all possible tests are ordered during a medical visit.

“However, as health care systems move toward a more value-based care system – where the benefit of services provided outweighs any risks – clinicians need to engage patients in these discussions on the complexity of this testing,” he commented. “Ultimately, when and if to screen is a decision best left between a provider and the patient.”

There was no outside funding and the authors reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Although moderately hypofractionated radiotherapy (MHRT) is an accepted treatment for localized prostate cancer, its adaptation remains limited in the United States.^1,2 MHRT theoretically exploits α/β ratio differences between the prostate (1.5 Gy), bladder (5-10 Gy), and rectum (3 Gy), thereby reducing late treatment-related adverse effects compared with those of conventional fractionation at biologically equivalent doses.^3-8 Multiple randomized noninferiority trials have demonstrated equivalent outcomes between MHRT and conventional fraction with no appreciable increase in patient-reported toxicity.^9-14 Although these studies have led to the acceptance of MHRT as a standard treatment, the majority of these trials involve individuals with low- and intermediate-risk disease.

There are less phase 3 data addressing MHRT for high-risk prostate cancer (HRPC).^10,12,14-17 Only 2 studies examined predominately high-risk populations, accounting for 83 and 292 patients, respectively.^15,16 Additional phase 3 trials with small proportions of high-risk patients (n = 126, 12%; n = 53, 35%) offer limited additional information regarding clinical outcomes and toxicity rates specific to high-risk disease.^10-12 Numerous phase 1 and 2 studies report various field designs and fractionation plans for MHRT in the context of high-risk disease, although the applicability of these data to off-trial populations remains limited.^18-20

Furthermore, African American individuals are underrepresented in the trials establishing the role of MHRT despite higher rates of prostate cancer incidence, more advanced disease stage at diagnosis, and higher rates of prostate cancer–specific survival (PCSS) when compared with White patients.²¹ Racial disparities across patients with prostate cancer and their management are multifactorial across health care literacy, education level, access to care (including transportation issues), and issues of adherence and distrust.^22-25 Correlation of patient race to prostate cancer outcomes varies greatly across health care systems, with the US Department of Veterans Affairs (VA) equal access system providing robust mental health services and transportation services for some patients, while demonstrating similar rates of stage-adjusted PCSS between African American and White patients across a broad range of treatment modalities.^26-28 Given the paucity of data exploring outcomes following MHRT for African American patients with HRPC, the present analysis provides long-term clinical outcomes and toxicity profiles for an off-trial majority African American population with HRPC treated with MHRT within the VA.

Methods

Records were retrospectively reviewed under an institutional review board–approved protocol for all patients with HRPC treated with definitive MHRT at the Durham Veterans Affairs Healthcare System in North Carolina between November 2008 and August 2018. Exclusion criteria included < 12 months of follow-up or elective nodal irradiation. Demographic variables obtained included age at diagnosis, race, clinical T stage, pre-MHRT prostate-specific antigen (PSA), Gleason grade group at diagnosis, favorable vs unfavorable high-risk disease, pre-MHRT international prostate symptom score (IPSS), and pre-MHRT urinary medication usage (yes/no).²⁹

Concurrent androgen deprivation therapy (ADT) was initiated 6 to 8 weeks before MHRT unless medically contraindicated per the discretion of the treating radiation oncologist. Patients generally received 18 to 24 months of ADT, with those with favorable HRPC (ie, T1c disease with either Gleason 4+4 and PSA < 10 mg/mL or Gleason 3+3 and PSA > 20 ng/mL) receiving 6 months after 2015.²⁹ Patients were simulated supine in either standard or custom immobilization with a full bladder and empty rectum. MHRT fractionation plans included 70 Gy at 2.5 Gy per fraction and 60 Gy at 3 Gy per fraction. Radiotherapy targets included the prostate and seminal vesicles without elective nodal coverage per institutional practice. Treatments were delivered following image guidance, either prostate matching with cone beam computed tomography or fiducial matching with kilo voltage imaging. All patients received intensity-modulated radiotherapy. For plans delivering 70 Gy at 2.5 Gy per fraction, constraints included bladder V (volume receiving) 70 < 10 cc, V65 ≤ 15%, V40 ≤ 35%, rectum V70 < 10 cc, V65 ≤ 10%, V40 ≤ 35%, femoral heads maximum point dose ≤ 40 Gy, penile bulb mean dose ≤ 50 Gy, and small bowel V40 ≤ 1%. For plans delivering 60 Gy at 3 Gy per fraction, constraints included rectum V57 ≤ 15%, V46 ≤ 30%, V37 ≤ 50%, bladder V60 ≤ 5%, V46 ≤ 30%, V37 ≤ 50%, and femoral heads V43 ≤ 5%.

Gastrointestinal (GI) and genitourinary (GU) toxicities were graded using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, with acute toxicity defined as on-treatment < 3 months following completion of MHRT. Late toxicity was defined as ≥ 3 months following completion of MHRT. Individuals were seen in follow-up at 6 weeks and 3 months with PSA and testosterone after MHRT completion, then every 6 to 12 months for 5 years and annually thereafter. Each follow-up visit included history, physical examination, IPSS, and CTCAE grading for GI and GU toxicity.

The Wilcoxon rank sum test and χ² test were used to compare differences in demographic data, dosimetric parameters, and frequency of toxicity events with respect to patient race. Clinical endpoints including biochemical recurrence-free survival (BRFS; defined by Phoenix criteria as 2.0 above PSA nadir), distant metastases-free survival (DMFS), PCSS, and overall survival (OS) were estimated from time of radiotherapy completion by the Kaplan-Meier method and compared between African American and White race by log-rank testing.³⁰ Late GI and GU toxicity-free survival were estimated by Kaplan-Meier plots and compared between African American and White patients by the log-rank test. Statistical analysis was performed using SAS 9.4.

Results

We identified 143 patients with HRPC treated with definitive MHRT between November 2008 and August 2018 (Table 1). Mean age was 65 years (range, 36-80 years); 57% were African American men. Eighty percent of individuals had unfavorable high-risk disease. Median (IQR) PSA was 14.4 (7.8-28.6). Twenty-six percent had grade group 1-3 disease, 47% had grade group 4 disease, and 27% had grade group 5 disease. African American patients had significantly lower pre-MHRT IPSS scores than White patients (mean IPSS, 11 vs 14, respectively; P = .02) despite similar rates of preradiotherapy urinary medication usage (66% and 66%, respectively).

Eighty-six percent received 70 Gy over 28 fractions, with institutional protocol shifting to 60 Gy over 20 fractions (14%) in June 2017. The median (IQR) duration of radiotherapy was 39 (38-42) days, with 97% of individuals undergoing ADT for a median (IQR) duration of 24 (24-36) months. The median follow-up time was 38 months, with 57 (40%) patients followed for at least 60 months.

Grade 3 GI and GU acute toxicity events were observed in 1% and 4% of all individuals, respectively (Table 2). No acute GI or GU grade 4+ events were observed. No significant differences in acute GU or GI toxicity were observed between African American and White patients.

Discussion

In this study, we reported acute and late GI and GU toxicity rates as well as clinical outcomes for a majority African American population with predominately unfavorable HRPC treated with MHRT in an equal access health care environment. We found that MHRT was well tolerated with high rates of biochemical control, PCSS, and OS. Additionally, outcomes were not significantly different across patient race. To our knowledge, this is the first report of MHRT for HRPC in a majority African American population.

We found that MHRT was an effective treatment for patients with HRPC, in particular those with unfavorable high-risk disease. While prior prospective and randomized studies have investigated the use of MHRT, our series was larger than most and had a predominately unfavorable high-risk population.^12,15-17 Our biochemical and PCSS rates compare favorably with those of HRPC trial populations, particularly given the high proportion of unfavorable high-risk disease.^12,15,16 Despite similar rates of biochemical control, OS was lower in the present cohort than in HRPC trial populations, even with a younger median age at diagnosis. The similarly high rates of non–HRPC-related death across race may reflect differences in baseline comorbidities compared with trial populations as well as reported differences between individuals in the VA and the private sector.³¹ This suggests that MHRT can be an effective treatment for patients with unfavorable HRPC.

We did not find any differences in outcomes between African American and White individuals with HRPC treated with MHRT. Furthermore, our study demonstrates long-term rates of BRFS and PCSS in a majority African American population with predominately unfavorable HRPC that are comparable with those of prior randomized MHRT studies in high-risk, predominately White populations.^12,15,16 Prior reports have found that African American men with HRPC may be at increased risk for inferior clinical outcomes due to a number of socioeconomic, biologic, and cultural mediators.^26,27,32 Such individuals may disproportionally benefit from shorter treatment courses that improve access to radiotherapy, a well-documented disparity for African American men with localized prostate cancer.^33-36 The VA is an ideal system for studying racial disparities within prostate cancer, as accessibility of mental health and transportation services, income, and insurance status are not barriers to preventative or acute care.³⁷ Our results are concordant with those previously seen for African American patients with prostate cancer seen in the VA, which similarly demonstrate equal outcomes with those of other races.^28,36 Incorporation of the earlier mentioned VA services into oncologic care across other health care systems could better characterize determinants of racial disparities in prostate cancer, including the prognostic significance of shortening treatment duration and number of patient visits via MHRT.

Limitations

This study has several inherent limitations. While the size of the current HRPC cohort is notably larger than similar populations within the majority of phase 3 MHRT trials, these data derive from a single VA hospital. It is unclear whether these outcomes would be representative in a similar high-risk population receiving care outside of the VA equal access system. Follow-up data beyond 5 years was available for less than half of patients, partially due to nonprostate cancer–related mortality at a higher rate than observed in HRPC trial populations.^12,15,16 Furthermore, all GI toxicity events were exclusively physician reported, and GU toxicity reporting was limited in the off-trial setting with not all patients routinely completing IPSS questionnaires following MHRT completion. However, all patients were treated similarly, and radiation quality was verified over the treatment period with mandated accreditation, frequent standardized output checks, and systematic treatment review.³⁹

Conclusions

Patients with HRPC treated with MHRT in an equal access, off-trial setting demonstrated favorable rates of biochemical control with acceptable rates of acute and late GI and GU toxicities. Clinical outcomes, including biochemical control, were not significantly different between African American and White patients, which may reflect equal access to care within the VA irrespective of income and insurance status. Incorporating VA services, such as access to primary care, mental health services, and transportation across other health care systems may aid in characterizing and mitigating racial and gender disparities in oncologic care.  

Acknowledgments

Portions of this work were presented at the November 2020 ASTRO conference. ⁴⁰

Although moderately hypofractionated radiotherapy (MHRT) is an accepted treatment for localized prostate cancer, its adaptation remains limited in the United States.^1,2 MHRT theoretically exploits α/β ratio differences between the prostate (1.5 Gy), bladder (5-10 Gy), and rectum (3 Gy), thereby reducing late treatment-related adverse effects compared with those of conventional fractionation at biologically equivalent doses.^3-8 Multiple randomized noninferiority trials have demonstrated equivalent outcomes between MHRT and conventional fraction with no appreciable increase in patient-reported toxicity.^9-14 Although these studies have led to the acceptance of MHRT as a standard treatment, the majority of these trials involve individuals with low- and intermediate-risk disease.

There are less phase 3 data addressing MHRT for high-risk prostate cancer (HRPC).^10,12,14-17 Only 2 studies examined predominately high-risk populations, accounting for 83 and 292 patients, respectively.^15,16 Additional phase 3 trials with small proportions of high-risk patients (n = 126, 12%; n = 53, 35%) offer limited additional information regarding clinical outcomes and toxicity rates specific to high-risk disease.^10-12 Numerous phase 1 and 2 studies report various field designs and fractionation plans for MHRT in the context of high-risk disease, although the applicability of these data to off-trial populations remains limited.^18-20

Furthermore, African American individuals are underrepresented in the trials establishing the role of MHRT despite higher rates of prostate cancer incidence, more advanced disease stage at diagnosis, and higher rates of prostate cancer–specific survival (PCSS) when compared with White patients.²¹ Racial disparities across patients with prostate cancer and their management are multifactorial across health care literacy, education level, access to care (including transportation issues), and issues of adherence and distrust.^22-25 Correlation of patient race to prostate cancer outcomes varies greatly across health care systems, with the US Department of Veterans Affairs (VA) equal access system providing robust mental health services and transportation services for some patients, while demonstrating similar rates of stage-adjusted PCSS between African American and White patients across a broad range of treatment modalities.^26-28 Given the paucity of data exploring outcomes following MHRT for African American patients with HRPC, the present analysis provides long-term clinical outcomes and toxicity profiles for an off-trial majority African American population with HRPC treated with MHRT within the VA.

Methods

Records were retrospectively reviewed under an institutional review board–approved protocol for all patients with HRPC treated with definitive MHRT at the Durham Veterans Affairs Healthcare System in North Carolina between November 2008 and August 2018. Exclusion criteria included < 12 months of follow-up or elective nodal irradiation. Demographic variables obtained included age at diagnosis, race, clinical T stage, pre-MHRT prostate-specific antigen (PSA), Gleason grade group at diagnosis, favorable vs unfavorable high-risk disease, pre-MHRT international prostate symptom score (IPSS), and pre-MHRT urinary medication usage (yes/no).²⁹

Concurrent androgen deprivation therapy (ADT) was initiated 6 to 8 weeks before MHRT unless medically contraindicated per the discretion of the treating radiation oncologist. Patients generally received 18 to 24 months of ADT, with those with favorable HRPC (ie, T1c disease with either Gleason 4+4 and PSA < 10 mg/mL or Gleason 3+3 and PSA > 20 ng/mL) receiving 6 months after 2015.²⁹ Patients were simulated supine in either standard or custom immobilization with a full bladder and empty rectum. MHRT fractionation plans included 70 Gy at 2.5 Gy per fraction and 60 Gy at 3 Gy per fraction. Radiotherapy targets included the prostate and seminal vesicles without elective nodal coverage per institutional practice. Treatments were delivered following image guidance, either prostate matching with cone beam computed tomography or fiducial matching with kilo voltage imaging. All patients received intensity-modulated radiotherapy. For plans delivering 70 Gy at 2.5 Gy per fraction, constraints included bladder V (volume receiving) 70 < 10 cc, V65 ≤ 15%, V40 ≤ 35%, rectum V70 < 10 cc, V65 ≤ 10%, V40 ≤ 35%, femoral heads maximum point dose ≤ 40 Gy, penile bulb mean dose ≤ 50 Gy, and small bowel V40 ≤ 1%. For plans delivering 60 Gy at 3 Gy per fraction, constraints included rectum V57 ≤ 15%, V46 ≤ 30%, V37 ≤ 50%, bladder V60 ≤ 5%, V46 ≤ 30%, V37 ≤ 50%, and femoral heads V43 ≤ 5%.

Gastrointestinal (GI) and genitourinary (GU) toxicities were graded using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, with acute toxicity defined as on-treatment < 3 months following completion of MHRT. Late toxicity was defined as ≥ 3 months following completion of MHRT. Individuals were seen in follow-up at 6 weeks and 3 months with PSA and testosterone after MHRT completion, then every 6 to 12 months for 5 years and annually thereafter. Each follow-up visit included history, physical examination, IPSS, and CTCAE grading for GI and GU toxicity.

The Wilcoxon rank sum test and χ² test were used to compare differences in demographic data, dosimetric parameters, and frequency of toxicity events with respect to patient race. Clinical endpoints including biochemical recurrence-free survival (BRFS; defined by Phoenix criteria as 2.0 above PSA nadir), distant metastases-free survival (DMFS), PCSS, and overall survival (OS) were estimated from time of radiotherapy completion by the Kaplan-Meier method and compared between African American and White race by log-rank testing.³⁰ Late GI and GU toxicity-free survival were estimated by Kaplan-Meier plots and compared between African American and White patients by the log-rank test. Statistical analysis was performed using SAS 9.4.

Results

We identified 143 patients with HRPC treated with definitive MHRT between November 2008 and August 2018 (Table 1). Mean age was 65 years (range, 36-80 years); 57% were African American men. Eighty percent of individuals had unfavorable high-risk disease. Median (IQR) PSA was 14.4 (7.8-28.6). Twenty-six percent had grade group 1-3 disease, 47% had grade group 4 disease, and 27% had grade group 5 disease. African American patients had significantly lower pre-MHRT IPSS scores than White patients (mean IPSS, 11 vs 14, respectively; P = .02) despite similar rates of preradiotherapy urinary medication usage (66% and 66%, respectively).

Eighty-six percent received 70 Gy over 28 fractions, with institutional protocol shifting to 60 Gy over 20 fractions (14%) in June 2017. The median (IQR) duration of radiotherapy was 39 (38-42) days, with 97% of individuals undergoing ADT for a median (IQR) duration of 24 (24-36) months. The median follow-up time was 38 months, with 57 (40%) patients followed for at least 60 months.

Grade 3 GI and GU acute toxicity events were observed in 1% and 4% of all individuals, respectively (Table 2). No acute GI or GU grade 4+ events were observed. No significant differences in acute GU or GI toxicity were observed between African American and White patients.

Discussion

In this study, we reported acute and late GI and GU toxicity rates as well as clinical outcomes for a majority African American population with predominately unfavorable HRPC treated with MHRT in an equal access health care environment. We found that MHRT was well tolerated with high rates of biochemical control, PCSS, and OS. Additionally, outcomes were not significantly different across patient race. To our knowledge, this is the first report of MHRT for HRPC in a majority African American population.

We found that MHRT was an effective treatment for patients with HRPC, in particular those with unfavorable high-risk disease. While prior prospective and randomized studies have investigated the use of MHRT, our series was larger than most and had a predominately unfavorable high-risk population.^12,15-17 Our biochemical and PCSS rates compare favorably with those of HRPC trial populations, particularly given the high proportion of unfavorable high-risk disease.^12,15,16 Despite similar rates of biochemical control, OS was lower in the present cohort than in HRPC trial populations, even with a younger median age at diagnosis. The similarly high rates of non–HRPC-related death across race may reflect differences in baseline comorbidities compared with trial populations as well as reported differences between individuals in the VA and the private sector.³¹ This suggests that MHRT can be an effective treatment for patients with unfavorable HRPC.

We did not find any differences in outcomes between African American and White individuals with HRPC treated with MHRT. Furthermore, our study demonstrates long-term rates of BRFS and PCSS in a majority African American population with predominately unfavorable HRPC that are comparable with those of prior randomized MHRT studies in high-risk, predominately White populations.^12,15,16 Prior reports have found that African American men with HRPC may be at increased risk for inferior clinical outcomes due to a number of socioeconomic, biologic, and cultural mediators.^26,27,32 Such individuals may disproportionally benefit from shorter treatment courses that improve access to radiotherapy, a well-documented disparity for African American men with localized prostate cancer.^33-36 The VA is an ideal system for studying racial disparities within prostate cancer, as accessibility of mental health and transportation services, income, and insurance status are not barriers to preventative or acute care.³⁷ Our results are concordant with those previously seen for African American patients with prostate cancer seen in the VA, which similarly demonstrate equal outcomes with those of other races.^28,36 Incorporation of the earlier mentioned VA services into oncologic care across other health care systems could better characterize determinants of racial disparities in prostate cancer, including the prognostic significance of shortening treatment duration and number of patient visits via MHRT.

Limitations

This study has several inherent limitations. While the size of the current HRPC cohort is notably larger than similar populations within the majority of phase 3 MHRT trials, these data derive from a single VA hospital. It is unclear whether these outcomes would be representative in a similar high-risk population receiving care outside of the VA equal access system. Follow-up data beyond 5 years was available for less than half of patients, partially due to nonprostate cancer–related mortality at a higher rate than observed in HRPC trial populations.^12,15,16 Furthermore, all GI toxicity events were exclusively physician reported, and GU toxicity reporting was limited in the off-trial setting with not all patients routinely completing IPSS questionnaires following MHRT completion. However, all patients were treated similarly, and radiation quality was verified over the treatment period with mandated accreditation, frequent standardized output checks, and systematic treatment review.³⁹

Conclusions

Patients with HRPC treated with MHRT in an equal access, off-trial setting demonstrated favorable rates of biochemical control with acceptable rates of acute and late GI and GU toxicities. Clinical outcomes, including biochemical control, were not significantly different between African American and White patients, which may reflect equal access to care within the VA irrespective of income and insurance status. Incorporating VA services, such as access to primary care, mental health services, and transportation across other health care systems may aid in characterizing and mitigating racial and gender disparities in oncologic care.  

Acknowledgments

Portions of this work were presented at the November 2020 ASTRO conference. ⁴⁰

Although moderately hypofractionated radiotherapy (MHRT) is an accepted treatment for localized prostate cancer, its adaptation remains limited in the United States.^1,2 MHRT theoretically exploits α/β ratio differences between the prostate (1.5 Gy), bladder (5-10 Gy), and rectum (3 Gy), thereby reducing late treatment-related adverse effects compared with those of conventional fractionation at biologically equivalent doses.^3-8 Multiple randomized noninferiority trials have demonstrated equivalent outcomes between MHRT and conventional fraction with no appreciable increase in patient-reported toxicity.^9-14 Although these studies have led to the acceptance of MHRT as a standard treatment, the majority of these trials involve individuals with low- and intermediate-risk disease.

There are less phase 3 data addressing MHRT for high-risk prostate cancer (HRPC).^10,12,14-17 Only 2 studies examined predominately high-risk populations, accounting for 83 and 292 patients, respectively.^15,16 Additional phase 3 trials with small proportions of high-risk patients (n = 126, 12%; n = 53, 35%) offer limited additional information regarding clinical outcomes and toxicity rates specific to high-risk disease.^10-12 Numerous phase 1 and 2 studies report various field designs and fractionation plans for MHRT in the context of high-risk disease, although the applicability of these data to off-trial populations remains limited.^18-20

Furthermore, African American individuals are underrepresented in the trials establishing the role of MHRT despite higher rates of prostate cancer incidence, more advanced disease stage at diagnosis, and higher rates of prostate cancer–specific survival (PCSS) when compared with White patients.²¹ Racial disparities across patients with prostate cancer and their management are multifactorial across health care literacy, education level, access to care (including transportation issues), and issues of adherence and distrust.^22-25 Correlation of patient race to prostate cancer outcomes varies greatly across health care systems, with the US Department of Veterans Affairs (VA) equal access system providing robust mental health services and transportation services for some patients, while demonstrating similar rates of stage-adjusted PCSS between African American and White patients across a broad range of treatment modalities.^26-28 Given the paucity of data exploring outcomes following MHRT for African American patients with HRPC, the present analysis provides long-term clinical outcomes and toxicity profiles for an off-trial majority African American population with HRPC treated with MHRT within the VA.

Methods

Records were retrospectively reviewed under an institutional review board–approved protocol for all patients with HRPC treated with definitive MHRT at the Durham Veterans Affairs Healthcare System in North Carolina between November 2008 and August 2018. Exclusion criteria included < 12 months of follow-up or elective nodal irradiation. Demographic variables obtained included age at diagnosis, race, clinical T stage, pre-MHRT prostate-specific antigen (PSA), Gleason grade group at diagnosis, favorable vs unfavorable high-risk disease, pre-MHRT international prostate symptom score (IPSS), and pre-MHRT urinary medication usage (yes/no).²⁹

Concurrent androgen deprivation therapy (ADT) was initiated 6 to 8 weeks before MHRT unless medically contraindicated per the discretion of the treating radiation oncologist. Patients generally received 18 to 24 months of ADT, with those with favorable HRPC (ie, T1c disease with either Gleason 4+4 and PSA < 10 mg/mL or Gleason 3+3 and PSA > 20 ng/mL) receiving 6 months after 2015.²⁹ Patients were simulated supine in either standard or custom immobilization with a full bladder and empty rectum. MHRT fractionation plans included 70 Gy at 2.5 Gy per fraction and 60 Gy at 3 Gy per fraction. Radiotherapy targets included the prostate and seminal vesicles without elective nodal coverage per institutional practice. Treatments were delivered following image guidance, either prostate matching with cone beam computed tomography or fiducial matching with kilo voltage imaging. All patients received intensity-modulated radiotherapy. For plans delivering 70 Gy at 2.5 Gy per fraction, constraints included bladder V (volume receiving) 70 < 10 cc, V65 ≤ 15%, V40 ≤ 35%, rectum V70 < 10 cc, V65 ≤ 10%, V40 ≤ 35%, femoral heads maximum point dose ≤ 40 Gy, penile bulb mean dose ≤ 50 Gy, and small bowel V40 ≤ 1%. For plans delivering 60 Gy at 3 Gy per fraction, constraints included rectum V57 ≤ 15%, V46 ≤ 30%, V37 ≤ 50%, bladder V60 ≤ 5%, V46 ≤ 30%, V37 ≤ 50%, and femoral heads V43 ≤ 5%.

Gastrointestinal (GI) and genitourinary (GU) toxicities were graded using Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, with acute toxicity defined as on-treatment < 3 months following completion of MHRT. Late toxicity was defined as ≥ 3 months following completion of MHRT. Individuals were seen in follow-up at 6 weeks and 3 months with PSA and testosterone after MHRT completion, then every 6 to 12 months for 5 years and annually thereafter. Each follow-up visit included history, physical examination, IPSS, and CTCAE grading for GI and GU toxicity.

The Wilcoxon rank sum test and χ² test were used to compare differences in demographic data, dosimetric parameters, and frequency of toxicity events with respect to patient race. Clinical endpoints including biochemical recurrence-free survival (BRFS; defined by Phoenix criteria as 2.0 above PSA nadir), distant metastases-free survival (DMFS), PCSS, and overall survival (OS) were estimated from time of radiotherapy completion by the Kaplan-Meier method and compared between African American and White race by log-rank testing.³⁰ Late GI and GU toxicity-free survival were estimated by Kaplan-Meier plots and compared between African American and White patients by the log-rank test. Statistical analysis was performed using SAS 9.4.

Results

We identified 143 patients with HRPC treated with definitive MHRT between November 2008 and August 2018 (Table 1). Mean age was 65 years (range, 36-80 years); 57% were African American men. Eighty percent of individuals had unfavorable high-risk disease. Median (IQR) PSA was 14.4 (7.8-28.6). Twenty-six percent had grade group 1-3 disease, 47% had grade group 4 disease, and 27% had grade group 5 disease. African American patients had significantly lower pre-MHRT IPSS scores than White patients (mean IPSS, 11 vs 14, respectively; P = .02) despite similar rates of preradiotherapy urinary medication usage (66% and 66%, respectively).

Eighty-six percent received 70 Gy over 28 fractions, with institutional protocol shifting to 60 Gy over 20 fractions (14%) in June 2017. The median (IQR) duration of radiotherapy was 39 (38-42) days, with 97% of individuals undergoing ADT for a median (IQR) duration of 24 (24-36) months. The median follow-up time was 38 months, with 57 (40%) patients followed for at least 60 months.

Grade 3 GI and GU acute toxicity events were observed in 1% and 4% of all individuals, respectively (Table 2). No acute GI or GU grade 4+ events were observed. No significant differences in acute GU or GI toxicity were observed between African American and White patients.

Discussion

In this study, we reported acute and late GI and GU toxicity rates as well as clinical outcomes for a majority African American population with predominately unfavorable HRPC treated with MHRT in an equal access health care environment. We found that MHRT was well tolerated with high rates of biochemical control, PCSS, and OS. Additionally, outcomes were not significantly different across patient race. To our knowledge, this is the first report of MHRT for HRPC in a majority African American population.

We found that MHRT was an effective treatment for patients with HRPC, in particular those with unfavorable high-risk disease. While prior prospective and randomized studies have investigated the use of MHRT, our series was larger than most and had a predominately unfavorable high-risk population.^12,15-17 Our biochemical and PCSS rates compare favorably with those of HRPC trial populations, particularly given the high proportion of unfavorable high-risk disease.^12,15,16 Despite similar rates of biochemical control, OS was lower in the present cohort than in HRPC trial populations, even with a younger median age at diagnosis. The similarly high rates of non–HRPC-related death across race may reflect differences in baseline comorbidities compared with trial populations as well as reported differences between individuals in the VA and the private sector.³¹ This suggests that MHRT can be an effective treatment for patients with unfavorable HRPC.

We did not find any differences in outcomes between African American and White individuals with HRPC treated with MHRT. Furthermore, our study demonstrates long-term rates of BRFS and PCSS in a majority African American population with predominately unfavorable HRPC that are comparable with those of prior randomized MHRT studies in high-risk, predominately White populations.^12,15,16 Prior reports have found that African American men with HRPC may be at increased risk for inferior clinical outcomes due to a number of socioeconomic, biologic, and cultural mediators.^26,27,32 Such individuals may disproportionally benefit from shorter treatment courses that improve access to radiotherapy, a well-documented disparity for African American men with localized prostate cancer.^33-36 The VA is an ideal system for studying racial disparities within prostate cancer, as accessibility of mental health and transportation services, income, and insurance status are not barriers to preventative or acute care.³⁷ Our results are concordant with those previously seen for African American patients with prostate cancer seen in the VA, which similarly demonstrate equal outcomes with those of other races.^28,36 Incorporation of the earlier mentioned VA services into oncologic care across other health care systems could better characterize determinants of racial disparities in prostate cancer, including the prognostic significance of shortening treatment duration and number of patient visits via MHRT.

Limitations

This study has several inherent limitations. While the size of the current HRPC cohort is notably larger than similar populations within the majority of phase 3 MHRT trials, these data derive from a single VA hospital. It is unclear whether these outcomes would be representative in a similar high-risk population receiving care outside of the VA equal access system. Follow-up data beyond 5 years was available for less than half of patients, partially due to nonprostate cancer–related mortality at a higher rate than observed in HRPC trial populations.^12,15,16 Furthermore, all GI toxicity events were exclusively physician reported, and GU toxicity reporting was limited in the off-trial setting with not all patients routinely completing IPSS questionnaires following MHRT completion. However, all patients were treated similarly, and radiation quality was verified over the treatment period with mandated accreditation, frequent standardized output checks, and systematic treatment review.³⁹

Conclusions

Patients with HRPC treated with MHRT in an equal access, off-trial setting demonstrated favorable rates of biochemical control with acceptable rates of acute and late GI and GU toxicities. Clinical outcomes, including biochemical control, were not significantly different between African American and White patients, which may reflect equal access to care within the VA irrespective of income and insurance status. Incorporating VA services, such as access to primary care, mental health services, and transportation across other health care systems may aid in characterizing and mitigating racial and gender disparities in oncologic care.  

Acknowledgments

Portions of this work were presented at the November 2020 ASTRO conference. ⁴⁰

On the basis of the patient's history and presentation, this is likely a case of adenocarcinoma of the prostate. Although most patients with prostate cancer are diagnosed on screening, when localized symptoms do occur, they may include urinary frequency, decreased urine stream, urinary urgency, and hematuria. In some cases, these signs and symptoms may well be related to age-associated prostate enlargement or other conditions; benign prostatic hyperplasia, for example, can manifest in urinary symptoms and even elevate PSA (but because this patient does not report pain, nonbacterial prostatitis is unlikely). Symptomatic patients older than 50 years, such as the one in this case, should be screened for prostate cancer. Those with a PSA > 10 ng/mL are more than 50% likely to have prostate cancer. 

National Comprehensive Cancer Network guidelines advise that needle biopsy of the prostate is indicated for tissue diagnosis in those with elevated PSA levels, preferably via a transrectal ultrasound. MRI can be used to assess lesions that are concerning for prostate cancer prior to biopsy. Lesions are then assigned Prostate Imaging Reporting and Data System (PI-RADS) scores depending on their location within the prostatic zones. A pathologic evaluation of the biopsy specimen will determine the patient's Gleason score. PSA density and PSA doubling time should be collected as well. The clinician should ask about high-risk germline mutations and estimate life expectancy because course of treatment is largely based on risk assessment.

Standard treatments for clinically localized prostate cancer include watchful waiting, active surveillance, radical prostatectomy, and radiation therapy. Active surveillance is often recommended for those who have very-low-risk disease because of the slow growth of certain types of prostate cancer. Radical prostatectomy is a viable option for any patient with localized disease that can be completely excised surgically, provided the patient has a life expectancy of 10 or more years and no serious comorbidities. In some patients, radical prostatectomy may be followed by radiation with or without a short course of hormone treatment, depending on risk factors for recurrence. Radiation therapy is also potentially curative in localized prostate cancer and may be delivered in the form of external-beam radiation therapy or brachytherapy. For asymptomatic patients who are older and/or have other serious underlying conditions, observation may be recommended.

Chad R. Tracy, MD, Professor; Director, Minimally Invasive Surgery, Department of Urology, University of Iowa Hospitals and Clinics, Iowa City, Iowa

Chad R. Tracy, MD, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: CVICO Medical Solutions.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

On the basis of the patient's history and presentation, this is likely a case of adenocarcinoma of the prostate. Although most patients with prostate cancer are diagnosed on screening, when localized symptoms do occur, they may include urinary frequency, decreased urine stream, urinary urgency, and hematuria. In some cases, these signs and symptoms may well be related to age-associated prostate enlargement or other conditions; benign prostatic hyperplasia, for example, can manifest in urinary symptoms and even elevate PSA (but because this patient does not report pain, nonbacterial prostatitis is unlikely). Symptomatic patients older than 50 years, such as the one in this case, should be screened for prostate cancer. Those with a PSA > 10 ng/mL are more than 50% likely to have prostate cancer. 

National Comprehensive Cancer Network guidelines advise that needle biopsy of the prostate is indicated for tissue diagnosis in those with elevated PSA levels, preferably via a transrectal ultrasound. MRI can be used to assess lesions that are concerning for prostate cancer prior to biopsy. Lesions are then assigned Prostate Imaging Reporting and Data System (PI-RADS) scores depending on their location within the prostatic zones. A pathologic evaluation of the biopsy specimen will determine the patient's Gleason score. PSA density and PSA doubling time should be collected as well. The clinician should ask about high-risk germline mutations and estimate life expectancy because course of treatment is largely based on risk assessment.

Standard treatments for clinically localized prostate cancer include watchful waiting, active surveillance, radical prostatectomy, and radiation therapy. Active surveillance is often recommended for those who have very-low-risk disease because of the slow growth of certain types of prostate cancer. Radical prostatectomy is a viable option for any patient with localized disease that can be completely excised surgically, provided the patient has a life expectancy of 10 or more years and no serious comorbidities. In some patients, radical prostatectomy may be followed by radiation with or without a short course of hormone treatment, depending on risk factors for recurrence. Radiation therapy is also potentially curative in localized prostate cancer and may be delivered in the form of external-beam radiation therapy or brachytherapy. For asymptomatic patients who are older and/or have other serious underlying conditions, observation may be recommended.

Chad R. Tracy, MD, Professor; Director, Minimally Invasive Surgery, Department of Urology, University of Iowa Hospitals and Clinics, Iowa City, Iowa

Chad R. Tracy, MD, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: CVICO Medical Solutions.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

On the basis of the patient's history and presentation, this is likely a case of adenocarcinoma of the prostate. Although most patients with prostate cancer are diagnosed on screening, when localized symptoms do occur, they may include urinary frequency, decreased urine stream, urinary urgency, and hematuria. In some cases, these signs and symptoms may well be related to age-associated prostate enlargement or other conditions; benign prostatic hyperplasia, for example, can manifest in urinary symptoms and even elevate PSA (but because this patient does not report pain, nonbacterial prostatitis is unlikely). Symptomatic patients older than 50 years, such as the one in this case, should be screened for prostate cancer. Those with a PSA > 10 ng/mL are more than 50% likely to have prostate cancer. 

National Comprehensive Cancer Network guidelines advise that needle biopsy of the prostate is indicated for tissue diagnosis in those with elevated PSA levels, preferably via a transrectal ultrasound. MRI can be used to assess lesions that are concerning for prostate cancer prior to biopsy. Lesions are then assigned Prostate Imaging Reporting and Data System (PI-RADS) scores depending on their location within the prostatic zones. A pathologic evaluation of the biopsy specimen will determine the patient's Gleason score. PSA density and PSA doubling time should be collected as well. The clinician should ask about high-risk germline mutations and estimate life expectancy because course of treatment is largely based on risk assessment.

Standard treatments for clinically localized prostate cancer include watchful waiting, active surveillance, radical prostatectomy, and radiation therapy. Active surveillance is often recommended for those who have very-low-risk disease because of the slow growth of certain types of prostate cancer. Radical prostatectomy is a viable option for any patient with localized disease that can be completely excised surgically, provided the patient has a life expectancy of 10 or more years and no serious comorbidities. In some patients, radical prostatectomy may be followed by radiation with or without a short course of hormone treatment, depending on risk factors for recurrence. Radiation therapy is also potentially curative in localized prostate cancer and may be delivered in the form of external-beam radiation therapy or brachytherapy. For asymptomatic patients who are older and/or have other serious underlying conditions, observation may be recommended.

Chad R. Tracy, MD, Professor; Director, Minimally Invasive Surgery, Department of Urology, University of Iowa Hospitals and Clinics, Iowa City, Iowa

Chad R. Tracy, MD, has disclosed the following relevant financial relationships:

Serve(d) as a consultant for: CVICO Medical Solutions.

Image Quizzes are fictional or fictionalized clinical scenarios intended to provide evidence-based educational takeaways.

The number of men with prostate cancer who opted for active surveillance (AS) doubled nationally between 2014 and 2021, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.

Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.

Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.

Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.

In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.

Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.

Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”

In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.

Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.

“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”

The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.

In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.

In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
 

Aiming higher

William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”

Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.

However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.

Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”

Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.

“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”

Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”

Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The number of men with prostate cancer who opted for active surveillance (AS) doubled nationally between 2014 and 2021, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.

Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.

Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.

Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.

In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.

Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.

Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”

In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.

Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.

“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”

The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.

In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.

In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
 

Aiming higher

William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”

Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.

However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.

Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”

Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.

“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”

Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”

Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The number of men with prostate cancer who opted for active surveillance (AS) doubled nationally between 2014 and 2021, according to experts who say the dramatic increase reflects a growing understanding among both researchers and patients that low-grade prostate tumors can be safely watched for years without requiring treatment.

Roughly 60% of men eligible for AS chose that approach in 2021, up from 27% in 2014 and less than 10% in 2010, according to panel member Matthew Cooperberg, MD, MPH, of University of California, San Francisco. He presented the data for a panel of the American Urological Association (AUA) at the group’s annual meeting in New Orleans.

Dr. Cooperberg attributed the hike in AS rates in the United States to the growing scientific literature and guidelines supportive of the approach, which calls for periodic assessments of low-risk tumors but no surgery, radiation, or other therapies. In Canada and parts of Europe, approximately 80%-90% of men who are eligible for AS choose that approach, experts said.

Earlier this month, the AUA and the American Society for Radiation Oncology released the strongest guidelines to date supporting AS for low-risk patients, and, for the first time, for select patients with favorable intermediate-risk prostate cancer.

In 2012, the U.S. Preventative Services Task Force (USPSTF) recommended against screening for prostate-specific antigen (PSA), concluding that the benefits of the test did not outweigh the risks, such as overdiagnosis and overtreatment of low-risk prostate cancer.

Urologists blamed the USPSTF policy for a decline in PSA screening and an uptick in the diagnosis of advanced prostate cancer.

Dr. Cooperberg said the shift served as “a bit of a wake-up call for at least a segment of the urology community that if we didn’t fix the overtreatment problem, we would never retake the chunks of the conversation about screening and early detection.”

In 2018, following protests by urologists and patient advocates, the USPSTF revised its statements to include shared decisionmaking for PSA testing in men aged 55-69 years, reflecting emerging evidence of longer-term benefits and widespread adoption of active surveillance after detection of low-risk disease.

Laurence Klotz, MD, the University of Toronto researcher who named and helped develop AS 30 years ago, and who was not on the AUA panel, said other factors also help to explain the growing interest in AS. These include an increasing consensus among experts on the value of the strategy, mounting public awareness of its benefits, the efforts of support and advocacy groups, and the arrival of more sophisticated imaging and biomarkers that help further refine risk.

“We’re shrinking the gray zone,” Dr. Klotz said. “Remaining resistance to AS is due to legitimate concerns about missing significant cancer and losing a patient to metastatic disease, and perhaps financial drivers, particularly with less invasive technologies like radiation and focal therapy.”

The national rate for AS increased from 26.5% in 2014, when data were first reported through the AUA’s AQUA data registry. AQUA’s data comes from electronic health records and included 27,289 patients with newly diagnosed low-risk prostate cancer.

In 2014, radical prostatectomy was the leading treatment in the low-risk population, with 29.7% of these patients overall opting for surgery, edging out external beam radiotherapy (EBRT) and AS, at 28.2% and 26.5% respectively.

In 2015, AS and EBRT overtook surgery, and by 2021, 59.6% of low-risk patients had chosen AS, followed by 20.9% for EBRT and 15.8% for prostatectomy.
 

Aiming higher

William Catalona, MD, a panel member from Northwestern University Feinberg School of Medicine, Chicago, said the AUA’s Prostate Cancer Active Surveillance Project has set a goal of 80% uptake of AS in patients with low-risk prostate cancer. Dr. Catalona, an early critic of AS, called that figure “optimal and realistic,” something that should happen “as soon as possible.”

Dr. Catalona said the 80% benchmark matches acceptance of AS within the U.S. Department of Veterans Affairs hospitals.

However, Dr. Klotz said the American culture of treatment, which is driven at least in part by financial incentives on the part of physicians, may prevent the growth of AS above 80% in this country.

Dr. Cooperberg said financial incentives are real. “I think it’s a small minority of docs that are heavily driven by the financial incentive, but it certainly exists,” he told this news organization. When you look at the extreme variation of active surveillance rates, there is no question that factors like reimbursement are going to play a role.”

Dr. Catalona, who through the first decade of the 2000s regularly debated Dr. Klotz about the concept of AS, said he today recommends AS when appropriate.

“The variability of AS adoption among practices and physicians varies from 0% to 100%. Therefore, some are too ‘tight’ in recommending AS and some are ‘too loose.’ I do not attempt to steer [patients] into treatment unless I believe that would be their best option. Nevertheless, some opt for surveillance when I believe they are making a mistake, and some opt for treatment when I believe surveillance would have been a rational choice.”

Dr. Cooperberg agreed that a personalized approach is important and that both physicians and patients should be flexible in their decisionmaking. “There will always be some men with low-grade disease who should get immediate treatment. For example, a young man with very high-volume disease, even if it’s Gleason 3+3,” he said. “If it is clearly inevitable that he’s going to need treatment, he could reasonably make a decision to get immediate treatment.”

Dr. Cooperberg, Dr. Klotz, and Dr. Catalona have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A team of experts is recommending that doctors forgo describing early, low-grade prostate tumors as “cancers” as a way to ease anxiety among patients and their families and reduce unnecessary treatment.

Physicians often advise that men with low-risk prostate tumors wait to see if the disease worsens – an approach called “active surveillance” – rather than rushing to treat the condition. After all, low-grade tumors rarely cause harm, and therapies such as radiation and surgery can carry serious side effects, including impotence and urinary leakage.

Yet doctors still label these lesions “cancer,” and as a result, some experts say, many men in the United States opt for treatment they don’t need.

In a new paper likely to stoke debate, experts from a range of disciplines, as well as one patient, argue that overtreatment could be reduced by removing the word “cancer” from low-risk disease. Tumors that rate 6 on the Gleason score (GS) cannot invade other organs but nonetheless scare patients into undergoing risky treatments, they argue. Fewer than 1% of men with GS6 prostate tumors experience metastatic disease or die from cancer within 15 years of the initial diagnosis, they report.

“No matter how much time a physician may spend downplaying the significance of a GS6 diagnosis or emphasizing the phrase low-risk, the words ‘you have cancer’ have a potent psychological effect on most men and their families,” they wrote in a paper published in the Journal of Clinical Oncology.

Dropping the C word for low-risk tumors, which make up about half of 268,000 prostate cancer diagnoses annually in the United States, is not a new idea. An independent panel convened by the National Institutes of Health proposed just that in 2011.

However, clinician support for the shift appears to be growing, said Scott Eggener, MD, a urologic oncologist and professor of surgery at the University of Chicago, and a coauthor of the new article.

Dr. Eggener said active surveillance has been increasing dramatically in the United States, to about 60% of patients with GS6. “We feel like the landscape is right now to be talking about this issue,” Dr. Eggener told this news organization.

Reducing unnecessary treatment, he and his coauthors argue, could reduce the cost of health care — and boost the benefit of prostate-specific antigen testing for prostate cancer, which the U.S. Preventive Services Task Force at the moment deems small.

In addition, patients with prostate cancer diagnoses encounter increased risk of depression and suicide, disqualification or higher rates for life insurance, and questions from family and friends if they choose active surveillance over treatment – all of which might be ameliorated by a change in terminology.

The word “cancer” has been dropped from bladder, cervical, and thyroid conditions and prostate abnormalities that used to be classified as Gleason 2 through 5, they noted.
 

Keeping the status quo

But some physicians say GS6 doesn’t need a name change.

From a scientific standpoint, GS6 disease has molecular hallmarks of cancer, according to Jonathan Epstein, MD, professor of pathology, urology, and oncology at Johns Hopkins University, Baltimore. More important, Dr. Epstein told Medscape, the classification does not guarantee that more serious cancer is not present, only that it has not been found yet in tissue samples.

Dr. Eggener acknowledged that while GS6 does have molecular markers associated with cancer – a fact that’s “challenging to reconcile with” – giving it another name “would still require surveillance, and since the window of opportunity for curing localized [prostate cancer] is typically measured in years or decades, evidence of histologic progression to a higher-grade cancer would far precede the potential time of future metastasis in the majority of cases.”

Still, Dr. Epstein worries that dropping the cancer designation may lead some patients to forgo active surveillance, which involves repeated imaging and biopsies to check for worse disease. Without such monitoring, he said, “if they do have higher grade cancer that’s unsampled, it will pose a threat to their life.”

Gleason 6 tumors “may progress, some significantly, or be incompletely sampled at the time of diagnosis. Both clinicians and patients need to understand such risk,” Peter Carroll, MD, MPH, a urologist at the University of California, San Francisco, who is critical of the proposed name change, told this news organization.

Regardless of what it’s called, Gleason 6 disease warrants close monitoring, said Joe Gallo, a 77-year-old Pennsylvania man whose high-risk cancer was detected during active surveillance. “If I had taken a laid-back, or less, approach” to monitoring, Mr. Gallo said, “necessary treatment may have been delayed and my condition may have become more serious.”

Some advocates say patients and their families need to be educated that cancer exists on a spectrum of severity.

Mark Lichty, 73, chairman of a support group called Active Surveillance Patients International, received a Gleason 6 diagnosis 17 years ago. He resisted treatment against medical advice, and the cancer never progressed.

Mr. Lichty said active surveillance has been more widely adopted in Sweden, where physicians assure patients that treatment is unnecessary and support systems exist. “Yes, a diagnosis of cancer is frightening,” he said in an interview. But “we can do a lot better in how we communicate the diagnosis.”

Dr. Eggener reported consulting or advisory roles with Sophiris Bio, Francis Medical, Insightec, Profound Medical, and Candel Therapeutics; speakers bureau at Janssen; and fees for travel, accommodations, and expenses from Janssen Biotech and Insightec; as well as an uncompensated relationship with Steba Biotech. The remaining coauthors reported several financial relationships, which are listed in the paper. Dr. Epstein and Dr. Carroll have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A team of experts is recommending that doctors forgo describing early, low-grade prostate tumors as “cancers” as a way to ease anxiety among patients and their families and reduce unnecessary treatment.

Physicians often advise that men with low-risk prostate tumors wait to see if the disease worsens – an approach called “active surveillance” – rather than rushing to treat the condition. After all, low-grade tumors rarely cause harm, and therapies such as radiation and surgery can carry serious side effects, including impotence and urinary leakage.

Yet doctors still label these lesions “cancer,” and as a result, some experts say, many men in the United States opt for treatment they don’t need.

In a new paper likely to stoke debate, experts from a range of disciplines, as well as one patient, argue that overtreatment could be reduced by removing the word “cancer” from low-risk disease. Tumors that rate 6 on the Gleason score (GS) cannot invade other organs but nonetheless scare patients into undergoing risky treatments, they argue. Fewer than 1% of men with GS6 prostate tumors experience metastatic disease or die from cancer within 15 years of the initial diagnosis, they report.

“No matter how much time a physician may spend downplaying the significance of a GS6 diagnosis or emphasizing the phrase low-risk, the words ‘you have cancer’ have a potent psychological effect on most men and their families,” they wrote in a paper published in the Journal of Clinical Oncology.

Dropping the C word for low-risk tumors, which make up about half of 268,000 prostate cancer diagnoses annually in the United States, is not a new idea. An independent panel convened by the National Institutes of Health proposed just that in 2011.

However, clinician support for the shift appears to be growing, said Scott Eggener, MD, a urologic oncologist and professor of surgery at the University of Chicago, and a coauthor of the new article.

Dr. Eggener said active surveillance has been increasing dramatically in the United States, to about 60% of patients with GS6. “We feel like the landscape is right now to be talking about this issue,” Dr. Eggener told this news organization.

Reducing unnecessary treatment, he and his coauthors argue, could reduce the cost of health care — and boost the benefit of prostate-specific antigen testing for prostate cancer, which the U.S. Preventive Services Task Force at the moment deems small.

In addition, patients with prostate cancer diagnoses encounter increased risk of depression and suicide, disqualification or higher rates for life insurance, and questions from family and friends if they choose active surveillance over treatment – all of which might be ameliorated by a change in terminology.

The word “cancer” has been dropped from bladder, cervical, and thyroid conditions and prostate abnormalities that used to be classified as Gleason 2 through 5, they noted.
 

Keeping the status quo

But some physicians say GS6 doesn’t need a name change.

From a scientific standpoint, GS6 disease has molecular hallmarks of cancer, according to Jonathan Epstein, MD, professor of pathology, urology, and oncology at Johns Hopkins University, Baltimore. More important, Dr. Epstein told Medscape, the classification does not guarantee that more serious cancer is not present, only that it has not been found yet in tissue samples.

Dr. Eggener acknowledged that while GS6 does have molecular markers associated with cancer – a fact that’s “challenging to reconcile with” – giving it another name “would still require surveillance, and since the window of opportunity for curing localized [prostate cancer] is typically measured in years or decades, evidence of histologic progression to a higher-grade cancer would far precede the potential time of future metastasis in the majority of cases.”

Still, Dr. Epstein worries that dropping the cancer designation may lead some patients to forgo active surveillance, which involves repeated imaging and biopsies to check for worse disease. Without such monitoring, he said, “if they do have higher grade cancer that’s unsampled, it will pose a threat to their life.”

Gleason 6 tumors “may progress, some significantly, or be incompletely sampled at the time of diagnosis. Both clinicians and patients need to understand such risk,” Peter Carroll, MD, MPH, a urologist at the University of California, San Francisco, who is critical of the proposed name change, told this news organization.

Regardless of what it’s called, Gleason 6 disease warrants close monitoring, said Joe Gallo, a 77-year-old Pennsylvania man whose high-risk cancer was detected during active surveillance. “If I had taken a laid-back, or less, approach” to monitoring, Mr. Gallo said, “necessary treatment may have been delayed and my condition may have become more serious.”

Some advocates say patients and their families need to be educated that cancer exists on a spectrum of severity.

Mark Lichty, 73, chairman of a support group called Active Surveillance Patients International, received a Gleason 6 diagnosis 17 years ago. He resisted treatment against medical advice, and the cancer never progressed.

Mr. Lichty said active surveillance has been more widely adopted in Sweden, where physicians assure patients that treatment is unnecessary and support systems exist. “Yes, a diagnosis of cancer is frightening,” he said in an interview. But “we can do a lot better in how we communicate the diagnosis.”

Dr. Eggener reported consulting or advisory roles with Sophiris Bio, Francis Medical, Insightec, Profound Medical, and Candel Therapeutics; speakers bureau at Janssen; and fees for travel, accommodations, and expenses from Janssen Biotech and Insightec; as well as an uncompensated relationship with Steba Biotech. The remaining coauthors reported several financial relationships, which are listed in the paper. Dr. Epstein and Dr. Carroll have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A team of experts is recommending that doctors forgo describing early, low-grade prostate tumors as “cancers” as a way to ease anxiety among patients and their families and reduce unnecessary treatment.

Physicians often advise that men with low-risk prostate tumors wait to see if the disease worsens – an approach called “active surveillance” – rather than rushing to treat the condition. After all, low-grade tumors rarely cause harm, and therapies such as radiation and surgery can carry serious side effects, including impotence and urinary leakage.

Yet doctors still label these lesions “cancer,” and as a result, some experts say, many men in the United States opt for treatment they don’t need.

In a new paper likely to stoke debate, experts from a range of disciplines, as well as one patient, argue that overtreatment could be reduced by removing the word “cancer” from low-risk disease. Tumors that rate 6 on the Gleason score (GS) cannot invade other organs but nonetheless scare patients into undergoing risky treatments, they argue. Fewer than 1% of men with GS6 prostate tumors experience metastatic disease or die from cancer within 15 years of the initial diagnosis, they report.

“No matter how much time a physician may spend downplaying the significance of a GS6 diagnosis or emphasizing the phrase low-risk, the words ‘you have cancer’ have a potent psychological effect on most men and their families,” they wrote in a paper published in the Journal of Clinical Oncology.

Dropping the C word for low-risk tumors, which make up about half of 268,000 prostate cancer diagnoses annually in the United States, is not a new idea. An independent panel convened by the National Institutes of Health proposed just that in 2011.

However, clinician support for the shift appears to be growing, said Scott Eggener, MD, a urologic oncologist and professor of surgery at the University of Chicago, and a coauthor of the new article.

Dr. Eggener said active surveillance has been increasing dramatically in the United States, to about 60% of patients with GS6. “We feel like the landscape is right now to be talking about this issue,” Dr. Eggener told this news organization.

Reducing unnecessary treatment, he and his coauthors argue, could reduce the cost of health care — and boost the benefit of prostate-specific antigen testing for prostate cancer, which the U.S. Preventive Services Task Force at the moment deems small.

In addition, patients with prostate cancer diagnoses encounter increased risk of depression and suicide, disqualification or higher rates for life insurance, and questions from family and friends if they choose active surveillance over treatment – all of which might be ameliorated by a change in terminology.

The word “cancer” has been dropped from bladder, cervical, and thyroid conditions and prostate abnormalities that used to be classified as Gleason 2 through 5, they noted.
 

Keeping the status quo

But some physicians say GS6 doesn’t need a name change.

From a scientific standpoint, GS6 disease has molecular hallmarks of cancer, according to Jonathan Epstein, MD, professor of pathology, urology, and oncology at Johns Hopkins University, Baltimore. More important, Dr. Epstein told Medscape, the classification does not guarantee that more serious cancer is not present, only that it has not been found yet in tissue samples.

Dr. Eggener acknowledged that while GS6 does have molecular markers associated with cancer – a fact that’s “challenging to reconcile with” – giving it another name “would still require surveillance, and since the window of opportunity for curing localized [prostate cancer] is typically measured in years or decades, evidence of histologic progression to a higher-grade cancer would far precede the potential time of future metastasis in the majority of cases.”

Still, Dr. Epstein worries that dropping the cancer designation may lead some patients to forgo active surveillance, which involves repeated imaging and biopsies to check for worse disease. Without such monitoring, he said, “if they do have higher grade cancer that’s unsampled, it will pose a threat to their life.”

Gleason 6 tumors “may progress, some significantly, or be incompletely sampled at the time of diagnosis. Both clinicians and patients need to understand such risk,” Peter Carroll, MD, MPH, a urologist at the University of California, San Francisco, who is critical of the proposed name change, told this news organization.

Regardless of what it’s called, Gleason 6 disease warrants close monitoring, said Joe Gallo, a 77-year-old Pennsylvania man whose high-risk cancer was detected during active surveillance. “If I had taken a laid-back, or less, approach” to monitoring, Mr. Gallo said, “necessary treatment may have been delayed and my condition may have become more serious.”

Some advocates say patients and their families need to be educated that cancer exists on a spectrum of severity.

Mark Lichty, 73, chairman of a support group called Active Surveillance Patients International, received a Gleason 6 diagnosis 17 years ago. He resisted treatment against medical advice, and the cancer never progressed.

Mr. Lichty said active surveillance has been more widely adopted in Sweden, where physicians assure patients that treatment is unnecessary and support systems exist. “Yes, a diagnosis of cancer is frightening,” he said in an interview. But “we can do a lot better in how we communicate the diagnosis.”

Dr. Eggener reported consulting or advisory roles with Sophiris Bio, Francis Medical, Insightec, Profound Medical, and Candel Therapeutics; speakers bureau at Janssen; and fees for travel, accommodations, and expenses from Janssen Biotech and Insightec; as well as an uncompensated relationship with Steba Biotech. The remaining coauthors reported several financial relationships, which are listed in the paper. Dr. Epstein and Dr. Carroll have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.

 

In this issue:

• Exposure-Related Cancers
• Cancer in Women
• Genitourinary Cancers
• Gastrointestinal Cancers
• Telehealth in Oncology
•  Precision Oncology
•  Palliative and Hospice Care
•  Alcohol and Cancer
•  Lung Cancer
•  Oropharyngeal Cancer
• Hematologic Cancers

Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:

Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.

Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.

 

In this issue:

• Exposure-Related Cancers
• Cancer in Women
• Genitourinary Cancers
• Gastrointestinal Cancers
• Telehealth in Oncology
•  Precision Oncology
•  Palliative and Hospice Care
•  Alcohol and Cancer
•  Lung Cancer
•  Oropharyngeal Cancer
• Hematologic Cancers

Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:

Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.

Federal Practitioner, in collaboration with the Association of VA Hematology/Oncology (AVAHO), present the 2022 edition of Cancer Data Trends (click to view the digital edition). This special issue provides updates on some of the top cancers and related concerns affecting veterans through original infographics and visual storytelling.

 

In this issue:

• Exposure-Related Cancers
• Cancer in Women
• Genitourinary Cancers
• Gastrointestinal Cancers
• Telehealth in Oncology
•  Precision Oncology
•  Palliative and Hospice Care
•  Alcohol and Cancer
•  Lung Cancer
•  Oropharyngeal Cancer
• Hematologic Cancers

Federal Practitioner and AVAHO would like to thank the following experts for their contributions to this issue:

Anita Aggarwal, DO, PhD; Sara Ahmed, PhD; Katherine Faricy-Anderson, MD; Apar Kishor Ganti, MD, MS; Solomon A Graf, MD; Kate Hendricks Thomas, PhD; Michael Kelley, MD; Mark Klein, MD, Gina McWhirter, MSN, MBA, RN; Bruce Montgomery, MD; Vida Almario Passero, MD, MBA; Thomas D Rodgers, MD; Vlad C Sandulache, MD, PhD; David H Wang, MD, PhD.