Genitourinary Cancer

SAN DIEGO – Prostate-specific antigen peptidase activity is higher in patients with less-aggressive prostate cancer than in patients with advanced disease, results from a pilot study demonstrated.

If the finding is confirmed by larger studies, this marker "may improve identification of men who may be better candidates for active surveillance," Dr. William J. Catalona said at the annual meeting of the American Urological Association. "In our study, if you considered those patients, it may have delayed or prevented surgery in 22% of this study population."

The marker, an assay developed by Ohmx under a National Institutes of Health small-business grant, "is a completely different approach to PSA testing," said Dr. Catalona, professor of urology at Northwestern University, Chicago.

"Current prostate cancer detection techniques generally suffer from a limited ability to differentiate indolent from aggressive prostate cancers," he explained. "We’re looking for tests that would detect life-threatening prostate cancer. That’s the real challenge in front of us today."

PSA peptidase activity was measured in a blinded study of 100 randomly selected patients who were treated with radical retropubic prostatectomy. Of the 100 patients, 50 had aggressive disease (defined as cancer resulting in prostate cancer–specific death, lymph node or distant metastases, seminal vesicle invasion, or extracapsular tumor extension), and 50 had nonaggressive disease (defined as cancer with a Gleason score of 6 or lower, pathologic stage T2, and no evidence of clinical or biochemical tumor recurrence on follow-up of 2-5 years). At surgery, fluid from the excised gland was gently milked from the apical urethral stump into a 2-mL conical vial and was immediately frozen at –80° C.

Next, researchers used a fluorogenic peptide probe to measure the level of proteolytic enzyme activity of PSA (aPSA) in each sample.

"All PSA tests measure the amount of PSA," said Dr. Catalona, who developed the PSA as a screening test for prostate cancer. "What this test focuses on is the enzymatic activity of PSA in prostatic fluid."

The aPSA value was significantly higher in patients with nonaggressive disease, compared with their counterparts who had advanced disease (a mean of 865 mcg/mL vs. a mean of 518 mcg/mL), a difference Dr. Catalona described as "striking." This reciprocal relationship between the PSA peptidase activity among the two patient groups "may improve identification of men who may be better candidates for active surveillance."

On receiver operating characteristic analysis, aPSA and the normalized ratio of aPSA to serum total PSA had the highest discriminatory power for predicting the presence of aggressive prostate cancer. Dr. Catalona estimated that using aPSA as an aggressiveness biomarker could result in 22% of the patients diagnosed with nonaggressive prostate cancer being able to avoid or delay radical prostatectomy.

Dr. Catalona said he and his associates plan to expand studies of the biomarker to include samples collected retrospectively before surgery, during attentive digital rectal exam.

The study was supported in part by a grant from the National Institutes of Health. Dr. Catalona disclosed that he received grant and research support from Beckman Coulter, Ohmx, and deCODE Genetics.

dbrunk@frontlinemedcom.com

SAN DIEGO – Prostate-specific antigen peptidase activity is higher in patients with less-aggressive prostate cancer than in patients with advanced disease, results from a pilot study demonstrated.

If the finding is confirmed by larger studies, this marker "may improve identification of men who may be better candidates for active surveillance," Dr. William J. Catalona said at the annual meeting of the American Urological Association. "In our study, if you considered those patients, it may have delayed or prevented surgery in 22% of this study population."

The marker, an assay developed by Ohmx under a National Institutes of Health small-business grant, "is a completely different approach to PSA testing," said Dr. Catalona, professor of urology at Northwestern University, Chicago.

"Current prostate cancer detection techniques generally suffer from a limited ability to differentiate indolent from aggressive prostate cancers," he explained. "We’re looking for tests that would detect life-threatening prostate cancer. That’s the real challenge in front of us today."

PSA peptidase activity was measured in a blinded study of 100 randomly selected patients who were treated with radical retropubic prostatectomy. Of the 100 patients, 50 had aggressive disease (defined as cancer resulting in prostate cancer–specific death, lymph node or distant metastases, seminal vesicle invasion, or extracapsular tumor extension), and 50 had nonaggressive disease (defined as cancer with a Gleason score of 6 or lower, pathologic stage T2, and no evidence of clinical or biochemical tumor recurrence on follow-up of 2-5 years). At surgery, fluid from the excised gland was gently milked from the apical urethral stump into a 2-mL conical vial and was immediately frozen at –80° C.

Next, researchers used a fluorogenic peptide probe to measure the level of proteolytic enzyme activity of PSA (aPSA) in each sample.

"All PSA tests measure the amount of PSA," said Dr. Catalona, who developed the PSA as a screening test for prostate cancer. "What this test focuses on is the enzymatic activity of PSA in prostatic fluid."

The aPSA value was significantly higher in patients with nonaggressive disease, compared with their counterparts who had advanced disease (a mean of 865 mcg/mL vs. a mean of 518 mcg/mL), a difference Dr. Catalona described as "striking." This reciprocal relationship between the PSA peptidase activity among the two patient groups "may improve identification of men who may be better candidates for active surveillance."

On receiver operating characteristic analysis, aPSA and the normalized ratio of aPSA to serum total PSA had the highest discriminatory power for predicting the presence of aggressive prostate cancer. Dr. Catalona estimated that using aPSA as an aggressiveness biomarker could result in 22% of the patients diagnosed with nonaggressive prostate cancer being able to avoid or delay radical prostatectomy.

Dr. Catalona said he and his associates plan to expand studies of the biomarker to include samples collected retrospectively before surgery, during attentive digital rectal exam.

The study was supported in part by a grant from the National Institutes of Health. Dr. Catalona disclosed that he received grant and research support from Beckman Coulter, Ohmx, and deCODE Genetics.

dbrunk@frontlinemedcom.com

SAN DIEGO – Prostate-specific antigen peptidase activity is higher in patients with less-aggressive prostate cancer than in patients with advanced disease, results from a pilot study demonstrated.

If the finding is confirmed by larger studies, this marker "may improve identification of men who may be better candidates for active surveillance," Dr. William J. Catalona said at the annual meeting of the American Urological Association. "In our study, if you considered those patients, it may have delayed or prevented surgery in 22% of this study population."

The marker, an assay developed by Ohmx under a National Institutes of Health small-business grant, "is a completely different approach to PSA testing," said Dr. Catalona, professor of urology at Northwestern University, Chicago.

"Current prostate cancer detection techniques generally suffer from a limited ability to differentiate indolent from aggressive prostate cancers," he explained. "We’re looking for tests that would detect life-threatening prostate cancer. That’s the real challenge in front of us today."

PSA peptidase activity was measured in a blinded study of 100 randomly selected patients who were treated with radical retropubic prostatectomy. Of the 100 patients, 50 had aggressive disease (defined as cancer resulting in prostate cancer–specific death, lymph node or distant metastases, seminal vesicle invasion, or extracapsular tumor extension), and 50 had nonaggressive disease (defined as cancer with a Gleason score of 6 or lower, pathologic stage T2, and no evidence of clinical or biochemical tumor recurrence on follow-up of 2-5 years). At surgery, fluid from the excised gland was gently milked from the apical urethral stump into a 2-mL conical vial and was immediately frozen at –80° C.

Next, researchers used a fluorogenic peptide probe to measure the level of proteolytic enzyme activity of PSA (aPSA) in each sample.

"All PSA tests measure the amount of PSA," said Dr. Catalona, who developed the PSA as a screening test for prostate cancer. "What this test focuses on is the enzymatic activity of PSA in prostatic fluid."

The aPSA value was significantly higher in patients with nonaggressive disease, compared with their counterparts who had advanced disease (a mean of 865 mcg/mL vs. a mean of 518 mcg/mL), a difference Dr. Catalona described as "striking." This reciprocal relationship between the PSA peptidase activity among the two patient groups "may improve identification of men who may be better candidates for active surveillance."

On receiver operating characteristic analysis, aPSA and the normalized ratio of aPSA to serum total PSA had the highest discriminatory power for predicting the presence of aggressive prostate cancer. Dr. Catalona estimated that using aPSA as an aggressiveness biomarker could result in 22% of the patients diagnosed with nonaggressive prostate cancer being able to avoid or delay radical prostatectomy.

Dr. Catalona said he and his associates plan to expand studies of the biomarker to include samples collected retrospectively before surgery, during attentive digital rectal exam.

The study was supported in part by a grant from the National Institutes of Health. Dr. Catalona disclosed that he received grant and research support from Beckman Coulter, Ohmx, and deCODE Genetics.

dbrunk@frontlinemedcom.com

SAN DIEGO – Testosterone replacement therapy is not associated with an increased risk of cancer or prostate cancer in men, based on results from a large study with a mean follow-up of nearly 9 years.

"We had hoped for these results," Dr. Michael L. Eisenberg said in an interview during a poster session at the annual meeting of the American Urological Association. "Certainly people are worried about testosterone in terms of prostate cancer development."

In a study conducted during his fellowship training in male reproductive medicine and microsurgery at Baylor College of Medicine, Houston, Dr. Eisenberg and his associates queried their database for all men with a serum testosterone level and then examined charts to determine testosterone replacement therapy (TRT) status. They limited their analysis to 750 men who lived in Texas and then linked the patient records to the Texas Cancer Registry to determine the incidence of cancer. Time at risk was measured from the date initiating TRT or from the first office visit for men not on TRT.

Of the 750 men, 333 (44%) were on TRT and 417 (56%) were not, reported Dr. Eisenberg, who is now director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center. Their mean age at study entry was 47 years, and they were followed for a mean of 8.7 years. Baseline testosterone levels were significantly lower in men on TRT compared with those who were not (a mean of 346 vs. 369 ng/dL, respectively; P less than 0.01).

Overall, 55 men developed cancer during the study period, including 22 men on TRT (6.6%) and 33 who were not on TRT (7.9%). When the researchers adjusted for age and year of evaluation, they found no significant difference in the risk of cancer based on TRT use (hazard ratio, 0.97).

Compared with the general Texas population, men on TRT had an age-adjusted standardized cancer incidence rate (SIR) of 1.5 while those not on TRT had a SIR of 1.7. When the researchers examined prostate cancer alone, they found that men on TRT had an age-adjusted SIR of 2.6 while those not on TRT had a SIR of 3.7. That particular finding is "very preliminary, but maybe there’s some possible protective effect of testosterone," said Dr. Eisenberg, who is also an assistant professor of urology at Stanford.

The study was funded by Endo Pharmaceuticals. Dr. Eisenberg said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – Testosterone replacement therapy is not associated with an increased risk of cancer or prostate cancer in men, based on results from a large study with a mean follow-up of nearly 9 years.

"We had hoped for these results," Dr. Michael L. Eisenberg said in an interview during a poster session at the annual meeting of the American Urological Association. "Certainly people are worried about testosterone in terms of prostate cancer development."

In a study conducted during his fellowship training in male reproductive medicine and microsurgery at Baylor College of Medicine, Houston, Dr. Eisenberg and his associates queried their database for all men with a serum testosterone level and then examined charts to determine testosterone replacement therapy (TRT) status. They limited their analysis to 750 men who lived in Texas and then linked the patient records to the Texas Cancer Registry to determine the incidence of cancer. Time at risk was measured from the date initiating TRT or from the first office visit for men not on TRT.

Of the 750 men, 333 (44%) were on TRT and 417 (56%) were not, reported Dr. Eisenberg, who is now director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center. Their mean age at study entry was 47 years, and they were followed for a mean of 8.7 years. Baseline testosterone levels were significantly lower in men on TRT compared with those who were not (a mean of 346 vs. 369 ng/dL, respectively; P less than 0.01).

Overall, 55 men developed cancer during the study period, including 22 men on TRT (6.6%) and 33 who were not on TRT (7.9%). When the researchers adjusted for age and year of evaluation, they found no significant difference in the risk of cancer based on TRT use (hazard ratio, 0.97).

Compared with the general Texas population, men on TRT had an age-adjusted standardized cancer incidence rate (SIR) of 1.5 while those not on TRT had a SIR of 1.7. When the researchers examined prostate cancer alone, they found that men on TRT had an age-adjusted SIR of 2.6 while those not on TRT had a SIR of 3.7. That particular finding is "very preliminary, but maybe there’s some possible protective effect of testosterone," said Dr. Eisenberg, who is also an assistant professor of urology at Stanford.

The study was funded by Endo Pharmaceuticals. Dr. Eisenberg said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – Testosterone replacement therapy is not associated with an increased risk of cancer or prostate cancer in men, based on results from a large study with a mean follow-up of nearly 9 years.

"We had hoped for these results," Dr. Michael L. Eisenberg said in an interview during a poster session at the annual meeting of the American Urological Association. "Certainly people are worried about testosterone in terms of prostate cancer development."

In a study conducted during his fellowship training in male reproductive medicine and microsurgery at Baylor College of Medicine, Houston, Dr. Eisenberg and his associates queried their database for all men with a serum testosterone level and then examined charts to determine testosterone replacement therapy (TRT) status. They limited their analysis to 750 men who lived in Texas and then linked the patient records to the Texas Cancer Registry to determine the incidence of cancer. Time at risk was measured from the date initiating TRT or from the first office visit for men not on TRT.

Of the 750 men, 333 (44%) were on TRT and 417 (56%) were not, reported Dr. Eisenberg, who is now director of male reproductive medicine and surgery at Stanford (Calif.) University Medical Center. Their mean age at study entry was 47 years, and they were followed for a mean of 8.7 years. Baseline testosterone levels were significantly lower in men on TRT compared with those who were not (a mean of 346 vs. 369 ng/dL, respectively; P less than 0.01).

Overall, 55 men developed cancer during the study period, including 22 men on TRT (6.6%) and 33 who were not on TRT (7.9%). When the researchers adjusted for age and year of evaluation, they found no significant difference in the risk of cancer based on TRT use (hazard ratio, 0.97).

Compared with the general Texas population, men on TRT had an age-adjusted standardized cancer incidence rate (SIR) of 1.5 while those not on TRT had a SIR of 1.7. When the researchers examined prostate cancer alone, they found that men on TRT had an age-adjusted SIR of 2.6 while those not on TRT had a SIR of 3.7. That particular finding is "very preliminary, but maybe there’s some possible protective effect of testosterone," said Dr. Eisenberg, who is also an assistant professor of urology at Stanford.

The study was funded by Endo Pharmaceuticals. Dr. Eisenberg said he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

A 58-year-old man was admitted to hospital with gross hematuria and a history of a prostate nodule that had been unchanged in size over a period of 3 years. A digital rectal examination revealed a nodule, confirmed by pelvic computed tomography and magnetic resonance imaging scans. Microscopic findings from a transrectal ultrasound-guided biopsy of the prostate revealed phyllodes tumor of the prostate and seminal vesicle, with well-differentiated fibrosarcoma and undifferentiated sarcoma. An initial prostate-specific antigen (PSA) value was 2 ng/mL (normal, less than 4 ng/dL). Over time, the mass grew in size and caused abdominal bloating, bladder outlet obstruction, and kidney failure. A radical prostatectomy was performed and the patient had an uneventful postoperative course. Thereafter, the patient received adjuvant radiation therapy. A few months after surgery, the symptoms worsened and imaging revealed a recurrence and metastasis to his lungs. The patient is currently receiving palliative chemotherapy.

*Click on the link to the left for a PDF of the full article.

A 58-year-old man was admitted to hospital with gross hematuria and a history of a prostate nodule that had been unchanged in size over a period of 3 years. A digital rectal examination revealed a nodule, confirmed by pelvic computed tomography and magnetic resonance imaging scans. Microscopic findings from a transrectal ultrasound-guided biopsy of the prostate revealed phyllodes tumor of the prostate and seminal vesicle, with well-differentiated fibrosarcoma and undifferentiated sarcoma. An initial prostate-specific antigen (PSA) value was 2 ng/mL (normal, less than 4 ng/dL). Over time, the mass grew in size and caused abdominal bloating, bladder outlet obstruction, and kidney failure. A radical prostatectomy was performed and the patient had an uneventful postoperative course. Thereafter, the patient received adjuvant radiation therapy. A few months after surgery, the symptoms worsened and imaging revealed a recurrence and metastasis to his lungs. The patient is currently receiving palliative chemotherapy.

*Click on the link to the left for a PDF of the full article.

A 58-year-old man was admitted to hospital with gross hematuria and a history of a prostate nodule that had been unchanged in size over a period of 3 years. A digital rectal examination revealed a nodule, confirmed by pelvic computed tomography and magnetic resonance imaging scans. Microscopic findings from a transrectal ultrasound-guided biopsy of the prostate revealed phyllodes tumor of the prostate and seminal vesicle, with well-differentiated fibrosarcoma and undifferentiated sarcoma. An initial prostate-specific antigen (PSA) value was 2 ng/mL (normal, less than 4 ng/dL). Over time, the mass grew in size and caused abdominal bloating, bladder outlet obstruction, and kidney failure. A radical prostatectomy was performed and the patient had an uneventful postoperative course. Thereafter, the patient received adjuvant radiation therapy. A few months after surgery, the symptoms worsened and imaging revealed a recurrence and metastasis to his lungs. The patient is currently receiving palliative chemotherapy.

*Click on the link to the left for a PDF of the full article.

SAN DIEGO – A blood test that detects the –2proPSA isoform of prostate-specific antigen may provide a way to reduce the number of unneeded prostate biopsies, results from a multicenter study showed.

Using a Prostate Health Index (phi) level of 27 as a threshold for selecting men for prostate cancer could eliminate unnecessary biopsies in 26% of men when total PSA is 4-10 ng/mL, said Dr. Martin G. Sanda, chief of urology at Emory University in Atlanta, during a press briefing at the annual meeting of the American Urological Association.

"This is a substantial portion of the population who may undergo PSA testing. [The index] would allow the ability to detect aggressive prostate cancer while having an acceptable false-negative rate. The Prostate Health Index has the potential to mitigate harms of overdetection/overtreatment of indolent cancers while retaining benefits of detecting aggressive prostate cancer which warrants treatment," he said.

The Prostate Health Index (phi), developed by Beckman Coulter and granted premarket approval from the Food and Drug Administration in June 2012, is a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4- to 10-ng/mL range and is shown to reduce the number of prostate biopsies.

"The Achilles’ heel of PSA detection in its current form is the overdetection and subsequently the downstream overtreatment of indolent prostate cancers," Dr. Sanda said. "The phi is a manner of reporting the detection of the –2proPSA isoform of PSA. This is a small subset of the PSA molecules, as opposed to the routine total PSA test that we are familiar with."

For the current study Dr. Sanda and his associates investigated whether the use of phi, compared with total PSA and the ratio of free to total PSA (%fPSA), could reduce unnecessary biopsies and overdetection of indolent prostate cancer while improving the detection of aggressive prostate cancer. He reported results from 658 men whose PSA was 4-10 ng/mL. Of these 658 men, 324 had prostate cancer. Among these 324 cancers, 160 were aggressive (meaning a Gleason score of 7 or greater) and 164 were indolent cancers.

Dr. Sanda reported that at 90% sensitivity, the specificity of phi was 31.1%, compared with 19.8% for %fPSA (P = .024) and 10.8% for PSA (P less than .001). When the phi ranged from 0 to 26.9, the probability of significant prostate cancer was 3.9% and rose sequentially with increasing range of phi. Specifically, the probability of significant prostate cancer was 8.5% for those with a phi of 27.0-35.9, 14.4% for those in the range of 36.0-54.9, and 28.9% for those with a phi level of 55 or higher.

"When phi is less than 27, the probability of one of these cancers being a Gleason score of 7 or higher was under 4%," said Dr. Sanda, who also directs the university’s Prostate Cancer Center. "With that particular threshold, we would be able to retain the benefits of being able to detect aggressive cancers in patients who had a biopsy when their phi was higher than 27 while avoiding unnecessary [biopsies] in about 26% of the men, substantially reducing the number of indolent cancers diagnosed and the number of unnecessary biopsies performed."

The false-positive rate was "in an acceptable range," he added. Only 4 out of 109 Gleason 3 + 4 cancers were missed (3.7%), and only 1 out of 35 Gleason 4 + 3 cancers was missed (2.9%).

"Because this is a straightforward serum assay, phi does have the potential to have a favorable cost profile relative to some of the genetic marker testing that’s coming down the pipeline," Dr. Sanda commented. "The next step is to validate these findings in a larger and separate cohort." That effort is currently underway with the Early Detection Research Network, a cohort study funded by the National Cancer Institute.

The study was funded by Beckman Coulter. Dr. Sanda disclosed that he is an investigator for the company. He also reported affiliations with Medicametrix, Accuray, and other companies.

dbrunk@frontlinemedcom.com

SAN DIEGO – A blood test that detects the –2proPSA isoform of prostate-specific antigen may provide a way to reduce the number of unneeded prostate biopsies, results from a multicenter study showed.

Using a Prostate Health Index (phi) level of 27 as a threshold for selecting men for prostate cancer could eliminate unnecessary biopsies in 26% of men when total PSA is 4-10 ng/mL, said Dr. Martin G. Sanda, chief of urology at Emory University in Atlanta, during a press briefing at the annual meeting of the American Urological Association.

"This is a substantial portion of the population who may undergo PSA testing. [The index] would allow the ability to detect aggressive prostate cancer while having an acceptable false-negative rate. The Prostate Health Index has the potential to mitigate harms of overdetection/overtreatment of indolent cancers while retaining benefits of detecting aggressive prostate cancer which warrants treatment," he said.

The Prostate Health Index (phi), developed by Beckman Coulter and granted premarket approval from the Food and Drug Administration in June 2012, is a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4- to 10-ng/mL range and is shown to reduce the number of prostate biopsies.

"The Achilles’ heel of PSA detection in its current form is the overdetection and subsequently the downstream overtreatment of indolent prostate cancers," Dr. Sanda said. "The phi is a manner of reporting the detection of the –2proPSA isoform of PSA. This is a small subset of the PSA molecules, as opposed to the routine total PSA test that we are familiar with."

For the current study Dr. Sanda and his associates investigated whether the use of phi, compared with total PSA and the ratio of free to total PSA (%fPSA), could reduce unnecessary biopsies and overdetection of indolent prostate cancer while improving the detection of aggressive prostate cancer. He reported results from 658 men whose PSA was 4-10 ng/mL. Of these 658 men, 324 had prostate cancer. Among these 324 cancers, 160 were aggressive (meaning a Gleason score of 7 or greater) and 164 were indolent cancers.

Dr. Sanda reported that at 90% sensitivity, the specificity of phi was 31.1%, compared with 19.8% for %fPSA (P = .024) and 10.8% for PSA (P less than .001). When the phi ranged from 0 to 26.9, the probability of significant prostate cancer was 3.9% and rose sequentially with increasing range of phi. Specifically, the probability of significant prostate cancer was 8.5% for those with a phi of 27.0-35.9, 14.4% for those in the range of 36.0-54.9, and 28.9% for those with a phi level of 55 or higher.

"When phi is less than 27, the probability of one of these cancers being a Gleason score of 7 or higher was under 4%," said Dr. Sanda, who also directs the university’s Prostate Cancer Center. "With that particular threshold, we would be able to retain the benefits of being able to detect aggressive cancers in patients who had a biopsy when their phi was higher than 27 while avoiding unnecessary [biopsies] in about 26% of the men, substantially reducing the number of indolent cancers diagnosed and the number of unnecessary biopsies performed."

The false-positive rate was "in an acceptable range," he added. Only 4 out of 109 Gleason 3 + 4 cancers were missed (3.7%), and only 1 out of 35 Gleason 4 + 3 cancers was missed (2.9%).

"Because this is a straightforward serum assay, phi does have the potential to have a favorable cost profile relative to some of the genetic marker testing that’s coming down the pipeline," Dr. Sanda commented. "The next step is to validate these findings in a larger and separate cohort." That effort is currently underway with the Early Detection Research Network, a cohort study funded by the National Cancer Institute.

The study was funded by Beckman Coulter. Dr. Sanda disclosed that he is an investigator for the company. He also reported affiliations with Medicametrix, Accuray, and other companies.

dbrunk@frontlinemedcom.com

SAN DIEGO – A blood test that detects the –2proPSA isoform of prostate-specific antigen may provide a way to reduce the number of unneeded prostate biopsies, results from a multicenter study showed.

Using a Prostate Health Index (phi) level of 27 as a threshold for selecting men for prostate cancer could eliminate unnecessary biopsies in 26% of men when total PSA is 4-10 ng/mL, said Dr. Martin G. Sanda, chief of urology at Emory University in Atlanta, during a press briefing at the annual meeting of the American Urological Association.

"This is a substantial portion of the population who may undergo PSA testing. [The index] would allow the ability to detect aggressive prostate cancer while having an acceptable false-negative rate. The Prostate Health Index has the potential to mitigate harms of overdetection/overtreatment of indolent cancers while retaining benefits of detecting aggressive prostate cancer which warrants treatment," he said.

The Prostate Health Index (phi), developed by Beckman Coulter and granted premarket approval from the Food and Drug Administration in June 2012, is a simple, noninvasive blood test that is 2.5 times more specific in detecting prostate cancer than PSA in patients with PSA values in the 4- to 10-ng/mL range and is shown to reduce the number of prostate biopsies.

"The Achilles’ heel of PSA detection in its current form is the overdetection and subsequently the downstream overtreatment of indolent prostate cancers," Dr. Sanda said. "The phi is a manner of reporting the detection of the –2proPSA isoform of PSA. This is a small subset of the PSA molecules, as opposed to the routine total PSA test that we are familiar with."

For the current study Dr. Sanda and his associates investigated whether the use of phi, compared with total PSA and the ratio of free to total PSA (%fPSA), could reduce unnecessary biopsies and overdetection of indolent prostate cancer while improving the detection of aggressive prostate cancer. He reported results from 658 men whose PSA was 4-10 ng/mL. Of these 658 men, 324 had prostate cancer. Among these 324 cancers, 160 were aggressive (meaning a Gleason score of 7 or greater) and 164 were indolent cancers.

Dr. Sanda reported that at 90% sensitivity, the specificity of phi was 31.1%, compared with 19.8% for %fPSA (P = .024) and 10.8% for PSA (P less than .001). When the phi ranged from 0 to 26.9, the probability of significant prostate cancer was 3.9% and rose sequentially with increasing range of phi. Specifically, the probability of significant prostate cancer was 8.5% for those with a phi of 27.0-35.9, 14.4% for those in the range of 36.0-54.9, and 28.9% for those with a phi level of 55 or higher.

"When phi is less than 27, the probability of one of these cancers being a Gleason score of 7 or higher was under 4%," said Dr. Sanda, who also directs the university’s Prostate Cancer Center. "With that particular threshold, we would be able to retain the benefits of being able to detect aggressive cancers in patients who had a biopsy when their phi was higher than 27 while avoiding unnecessary [biopsies] in about 26% of the men, substantially reducing the number of indolent cancers diagnosed and the number of unnecessary biopsies performed."

The false-positive rate was "in an acceptable range," he added. Only 4 out of 109 Gleason 3 + 4 cancers were missed (3.7%), and only 1 out of 35 Gleason 4 + 3 cancers was missed (2.9%).

"Because this is a straightforward serum assay, phi does have the potential to have a favorable cost profile relative to some of the genetic marker testing that’s coming down the pipeline," Dr. Sanda commented. "The next step is to validate these findings in a larger and separate cohort." That effort is currently underway with the Early Detection Research Network, a cohort study funded by the National Cancer Institute.

The study was funded by Beckman Coulter. Dr. Sanda disclosed that he is an investigator for the company. He also reported affiliations with Medicametrix, Accuray, and other companies.

dbrunk@frontlinemedcom.com

SAN DIEGO – The mean survival of men who initially presented with a prostate-specific antigen score of 100 ng/mL or greater was just 18 months, results from a single-center study showed.

In an effort to provide insight into the consequences of not screening for prostate cancer, researchers at Santa Clara Valley Medical Center, San Jose, Calif., – a county hospital affiliated with the Stanford (Calif.) University that serves a large underinsured population – evaluated the impact of initial prostate-specific antigen (PSA) levels of 100 ng/mL or greater on patient morbidity and mortality. "What we hypothesized is that they would do pretty well because with newer forms of treatment, and once they get into our system, we have comprehensive care that we can provide to them," Dr. Jeffrey H. Reese, chief of the division of urology at Santa Clara Valley Medical Center, said during a press briefing at the annual meeting of the American Urological Association. However, "what we found is that they did not do well at all."

Dr. Reese reported results from 71 men with a mean age of 67 years who presented with a mean PSA score of 100 ng/mL or greater between 1998 and 2008 – none of whom had received a prior prostate cancer screening at the medical center. The median PSA at presentation was 399 ng/mL, and the median survival was 18 months. "These patients did profoundly worse than what we would have expected," Dr. Reese said. Only 9.6% of the patients survived beyond 3 years.

About 80% of patients had chronic pain from their disease. Common comorbidities included hospitalization (64%), chronic catheterization (29%), spinal cord compression (19%), and compression fracture (17%).

"There are a variety of reasons why [these men] are not being screened," Dr. Reese said. "This is a population that either has no health insurance or minimal health insurance. Some were brought in by concerned family members. Some were immigrants. I think our public hospitals represent a snapshot of what prostate cancer was like before PSA screening. It was not uncommon to have these patients come in with widely metastatic disease. There would be consequences to not screening for PSA, if we were just to abandon it entirely."

He described death from prostate cancer as "a really bad way to die. It’s painful and prolonged. There’s a profound price to pay for this disease."

Study coauthor Dr. Winifred Adams, a urology fellow at the Stanford University, acknowledged that the relatively small sample of 71 patients was a limitation. "We wonder: Is this just a problem of metastatic disease, or is it more of a PSA issue of over 100? So we need to go back and look at all patients with metastatic disease versus those who have PSA over 100 and see if the outcome is the same," Dr. Adams said.

The researchers reported having no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – The mean survival of men who initially presented with a prostate-specific antigen score of 100 ng/mL or greater was just 18 months, results from a single-center study showed.

In an effort to provide insight into the consequences of not screening for prostate cancer, researchers at Santa Clara Valley Medical Center, San Jose, Calif., – a county hospital affiliated with the Stanford (Calif.) University that serves a large underinsured population – evaluated the impact of initial prostate-specific antigen (PSA) levels of 100 ng/mL or greater on patient morbidity and mortality. "What we hypothesized is that they would do pretty well because with newer forms of treatment, and once they get into our system, we have comprehensive care that we can provide to them," Dr. Jeffrey H. Reese, chief of the division of urology at Santa Clara Valley Medical Center, said during a press briefing at the annual meeting of the American Urological Association. However, "what we found is that they did not do well at all."

Dr. Reese reported results from 71 men with a mean age of 67 years who presented with a mean PSA score of 100 ng/mL or greater between 1998 and 2008 – none of whom had received a prior prostate cancer screening at the medical center. The median PSA at presentation was 399 ng/mL, and the median survival was 18 months. "These patients did profoundly worse than what we would have expected," Dr. Reese said. Only 9.6% of the patients survived beyond 3 years.

About 80% of patients had chronic pain from their disease. Common comorbidities included hospitalization (64%), chronic catheterization (29%), spinal cord compression (19%), and compression fracture (17%).

"There are a variety of reasons why [these men] are not being screened," Dr. Reese said. "This is a population that either has no health insurance or minimal health insurance. Some were brought in by concerned family members. Some were immigrants. I think our public hospitals represent a snapshot of what prostate cancer was like before PSA screening. It was not uncommon to have these patients come in with widely metastatic disease. There would be consequences to not screening for PSA, if we were just to abandon it entirely."

He described death from prostate cancer as "a really bad way to die. It’s painful and prolonged. There’s a profound price to pay for this disease."

Study coauthor Dr. Winifred Adams, a urology fellow at the Stanford University, acknowledged that the relatively small sample of 71 patients was a limitation. "We wonder: Is this just a problem of metastatic disease, or is it more of a PSA issue of over 100? So we need to go back and look at all patients with metastatic disease versus those who have PSA over 100 and see if the outcome is the same," Dr. Adams said.

The researchers reported having no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – The mean survival of men who initially presented with a prostate-specific antigen score of 100 ng/mL or greater was just 18 months, results from a single-center study showed.

In an effort to provide insight into the consequences of not screening for prostate cancer, researchers at Santa Clara Valley Medical Center, San Jose, Calif., – a county hospital affiliated with the Stanford (Calif.) University that serves a large underinsured population – evaluated the impact of initial prostate-specific antigen (PSA) levels of 100 ng/mL or greater on patient morbidity and mortality. "What we hypothesized is that they would do pretty well because with newer forms of treatment, and once they get into our system, we have comprehensive care that we can provide to them," Dr. Jeffrey H. Reese, chief of the division of urology at Santa Clara Valley Medical Center, said during a press briefing at the annual meeting of the American Urological Association. However, "what we found is that they did not do well at all."

Dr. Reese reported results from 71 men with a mean age of 67 years who presented with a mean PSA score of 100 ng/mL or greater between 1998 and 2008 – none of whom had received a prior prostate cancer screening at the medical center. The median PSA at presentation was 399 ng/mL, and the median survival was 18 months. "These patients did profoundly worse than what we would have expected," Dr. Reese said. Only 9.6% of the patients survived beyond 3 years.

About 80% of patients had chronic pain from their disease. Common comorbidities included hospitalization (64%), chronic catheterization (29%), spinal cord compression (19%), and compression fracture (17%).

"There are a variety of reasons why [these men] are not being screened," Dr. Reese said. "This is a population that either has no health insurance or minimal health insurance. Some were brought in by concerned family members. Some were immigrants. I think our public hospitals represent a snapshot of what prostate cancer was like before PSA screening. It was not uncommon to have these patients come in with widely metastatic disease. There would be consequences to not screening for PSA, if we were just to abandon it entirely."

He described death from prostate cancer as "a really bad way to die. It’s painful and prolonged. There’s a profound price to pay for this disease."

Study coauthor Dr. Winifred Adams, a urology fellow at the Stanford University, acknowledged that the relatively small sample of 71 patients was a limitation. "We wonder: Is this just a problem of metastatic disease, or is it more of a PSA issue of over 100? So we need to go back and look at all patients with metastatic disease versus those who have PSA over 100 and see if the outcome is the same," Dr. Adams said.

The researchers reported having no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

Surveillance is sufficient for most men with stage I seminoma after successful orchiectomy, according to the findings of the largest study ever performed to address the issue.

The 1,822 men followed only with surveillance in Denmark had an excellent disease-specific survival of 99.5%, Dr. Mette Saskø Mortensen said at a press briefing highlighting research to be presented at the upcoming American Society of Clinical Oncology annual meeting. Only 10 men died of testicular cancer or treatment-related causes during a median follow-up of 15.4 years.

This finding means that for every 1,000 men followed by a surveillance program, only 4 will die within 10 years, said incoming ASCO president Dr. Clifford Hudis, chief of breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York.

He described the study as one of several recent reminders that sometimes "less is more" in patient care and noted that opting for surveillance spares patients from the harmful side effects of chemotherapy and radiation without diminishing their chances for long-term survival.

Seminoma is a relatively rare cancer, but it is the most common solid tumor among young men. Initial treatment is typically orchiectomy, but no standard postoperative management strategy has been established. The current results will likely accelerate the trend toward surveillance in the United States, where roughly 50% of men undergo either radiotherapy or chemotherapy with carboplatin after surgery.

Overall, 355 (19.5%) of the 1,822 men experienced a relapse during surveillance, said Dr. Mortensen, a PhD student in the oncology department at Copenhagen University Hospital.

The median time to relapse was 13.7 months, with the majority of patients (72.4%) relapsing within the first 2 years. Another 20.3% relapsed within years 2-5 and 7.3% after 5 years.

"With only 19.5% of the patients relapsing, the surveillance strategy spares the remaining 80% of patients from unnecessary treatment after orchiectomy," Dr. Mortensen said. "Surveillance is a safe strategy for stage I seminoma patients."

Surveillance has been the main follow-up strategy for stage I seminoma in Denmark since 1984, and consists of 5 years of scheduled clinical visits, computed tomography scans/chest x-rays, and blood measurements of tumor markers. Men in the analysis were diagnosed from 1984 to 2008, and their data were collected up to December 2012 from patient files and linked national registries.

As observed in other smaller studies, the risk for relapse was increased with elevated human chorionic gonadotropin levels of more than 200 IU/L, vascular invasion, and tumors larger than 4 cm, Dr. Mortensen said.

The study was supported in part by the Danish Cancer Society, Danish Research Foundation and the Preben and Anna Simonsen Foundation. Dr. Mortensen reported having no financial disclosures.

pwendling@frontlinemedcom.com

Surveillance is sufficient for most men with stage I seminoma after successful orchiectomy, according to the findings of the largest study ever performed to address the issue.

The 1,822 men followed only with surveillance in Denmark had an excellent disease-specific survival of 99.5%, Dr. Mette Saskø Mortensen said at a press briefing highlighting research to be presented at the upcoming American Society of Clinical Oncology annual meeting. Only 10 men died of testicular cancer or treatment-related causes during a median follow-up of 15.4 years.

This finding means that for every 1,000 men followed by a surveillance program, only 4 will die within 10 years, said incoming ASCO president Dr. Clifford Hudis, chief of breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York.

He described the study as one of several recent reminders that sometimes "less is more" in patient care and noted that opting for surveillance spares patients from the harmful side effects of chemotherapy and radiation without diminishing their chances for long-term survival.

Seminoma is a relatively rare cancer, but it is the most common solid tumor among young men. Initial treatment is typically orchiectomy, but no standard postoperative management strategy has been established. The current results will likely accelerate the trend toward surveillance in the United States, where roughly 50% of men undergo either radiotherapy or chemotherapy with carboplatin after surgery.

Overall, 355 (19.5%) of the 1,822 men experienced a relapse during surveillance, said Dr. Mortensen, a PhD student in the oncology department at Copenhagen University Hospital.

The median time to relapse was 13.7 months, with the majority of patients (72.4%) relapsing within the first 2 years. Another 20.3% relapsed within years 2-5 and 7.3% after 5 years.

"With only 19.5% of the patients relapsing, the surveillance strategy spares the remaining 80% of patients from unnecessary treatment after orchiectomy," Dr. Mortensen said. "Surveillance is a safe strategy for stage I seminoma patients."

Surveillance has been the main follow-up strategy for stage I seminoma in Denmark since 1984, and consists of 5 years of scheduled clinical visits, computed tomography scans/chest x-rays, and blood measurements of tumor markers. Men in the analysis were diagnosed from 1984 to 2008, and their data were collected up to December 2012 from patient files and linked national registries.

As observed in other smaller studies, the risk for relapse was increased with elevated human chorionic gonadotropin levels of more than 200 IU/L, vascular invasion, and tumors larger than 4 cm, Dr. Mortensen said.

The study was supported in part by the Danish Cancer Society, Danish Research Foundation and the Preben and Anna Simonsen Foundation. Dr. Mortensen reported having no financial disclosures.

pwendling@frontlinemedcom.com

Surveillance is sufficient for most men with stage I seminoma after successful orchiectomy, according to the findings of the largest study ever performed to address the issue.

The 1,822 men followed only with surveillance in Denmark had an excellent disease-specific survival of 99.5%, Dr. Mette Saskø Mortensen said at a press briefing highlighting research to be presented at the upcoming American Society of Clinical Oncology annual meeting. Only 10 men died of testicular cancer or treatment-related causes during a median follow-up of 15.4 years.

This finding means that for every 1,000 men followed by a surveillance program, only 4 will die within 10 years, said incoming ASCO president Dr. Clifford Hudis, chief of breast cancer medicine service at Memorial Sloan-Kettering Cancer Center in New York.

He described the study as one of several recent reminders that sometimes "less is more" in patient care and noted that opting for surveillance spares patients from the harmful side effects of chemotherapy and radiation without diminishing their chances for long-term survival.

Seminoma is a relatively rare cancer, but it is the most common solid tumor among young men. Initial treatment is typically orchiectomy, but no standard postoperative management strategy has been established. The current results will likely accelerate the trend toward surveillance in the United States, where roughly 50% of men undergo either radiotherapy or chemotherapy with carboplatin after surgery.

Overall, 355 (19.5%) of the 1,822 men experienced a relapse during surveillance, said Dr. Mortensen, a PhD student in the oncology department at Copenhagen University Hospital.

The median time to relapse was 13.7 months, with the majority of patients (72.4%) relapsing within the first 2 years. Another 20.3% relapsed within years 2-5 and 7.3% after 5 years.

"With only 19.5% of the patients relapsing, the surveillance strategy spares the remaining 80% of patients from unnecessary treatment after orchiectomy," Dr. Mortensen said. "Surveillance is a safe strategy for stage I seminoma patients."

Surveillance has been the main follow-up strategy for stage I seminoma in Denmark since 1984, and consists of 5 years of scheduled clinical visits, computed tomography scans/chest x-rays, and blood measurements of tumor markers. Men in the analysis were diagnosed from 1984 to 2008, and their data were collected up to December 2012 from patient files and linked national registries.

As observed in other smaller studies, the risk for relapse was increased with elevated human chorionic gonadotropin levels of more than 200 IU/L, vascular invasion, and tumors larger than 4 cm, Dr. Mortensen said.

The study was supported in part by the Danish Cancer Society, Danish Research Foundation and the Preben and Anna Simonsen Foundation. Dr. Mortensen reported having no financial disclosures.

pwendling@frontlinemedcom.com

Radium-223 dichloride, an alpha-particle–emitting radioactive agent, has been approved for treating men with castration-resistant prostate cancer that has spread to the bones, the Food and Drug Administration announced on May 15.

The agent "binds with minerals in the bone to deliver radiation directly to bone tumors," Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, noted in the statement.

Ra-223 is the second drug for prostate cancer approved by the FDA in the last year that has been shown to extend the survival of men with metastatic prostate cancer, Dr. Pazdur noted. Enzalutamide (Xtandi), an androgen receptor inhibitor, was approved in August 2012 for treating men with metastatic castration-resistant prostate cancer who were previously treated with docetaxel.

Approval of the radium-223 treatment, which will be marketed as Xofigo by Bayer Pharmaceuticals, was based on a phase III study of men with symptomatic castration-resistant prostate cancer with symptomatic bone metastases, and no other metastases, randomized to treatment with radium 233 (541 men) every 4 weeks for six cycles or placebo (268 men). All patients received best standard of care, which included external-beam radiation therapy, corticosteroids, antiandrogens, estrogens, estramustine, or ketoconazole.

In an interim analysis, overall survival, the primary endpoint, was a median of 14 months among those in the radiotherapy arm, compared with 11.2 months among those on placebo, a highly statistically significant improvement, with a hazard ratio of 0.695. An updated exploratory analysis conducted later in the trial "confirmed Xofigo’s ability to extend overall survival," the FDA statement noted.

(The prescribing information states that in the updated analysis, median survival was 14.9 months vs. 11.3 months among those on placebo, with a hazard ratio of 0.695).

The most common side effects reported during clinical trials in men receiving the treatment, in 10% or more of patients, were nausea, diarrhea, vomiting and peripheral edema. The most common laboratory abnormalities detected, in 10% or more of patients, were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

Xofigo comes in a solution and is administered at 4-week intervals for six injection cycles; it is slowly administered intravenously over 1 minute. Safety and efficacy of more than six injections has not been studied, according to the prescribing information.

emechcatie@frontlinemedcom.com

Radium-223 dichloride, an alpha-particle–emitting radioactive agent, has been approved for treating men with castration-resistant prostate cancer that has spread to the bones, the Food and Drug Administration announced on May 15.

The agent "binds with minerals in the bone to deliver radiation directly to bone tumors," Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, noted in the statement.

Ra-223 is the second drug for prostate cancer approved by the FDA in the last year that has been shown to extend the survival of men with metastatic prostate cancer, Dr. Pazdur noted. Enzalutamide (Xtandi), an androgen receptor inhibitor, was approved in August 2012 for treating men with metastatic castration-resistant prostate cancer who were previously treated with docetaxel.

Approval of the radium-223 treatment, which will be marketed as Xofigo by Bayer Pharmaceuticals, was based on a phase III study of men with symptomatic castration-resistant prostate cancer with symptomatic bone metastases, and no other metastases, randomized to treatment with radium 233 (541 men) every 4 weeks for six cycles or placebo (268 men). All patients received best standard of care, which included external-beam radiation therapy, corticosteroids, antiandrogens, estrogens, estramustine, or ketoconazole.

In an interim analysis, overall survival, the primary endpoint, was a median of 14 months among those in the radiotherapy arm, compared with 11.2 months among those on placebo, a highly statistically significant improvement, with a hazard ratio of 0.695. An updated exploratory analysis conducted later in the trial "confirmed Xofigo’s ability to extend overall survival," the FDA statement noted.

(The prescribing information states that in the updated analysis, median survival was 14.9 months vs. 11.3 months among those on placebo, with a hazard ratio of 0.695).

The most common side effects reported during clinical trials in men receiving the treatment, in 10% or more of patients, were nausea, diarrhea, vomiting and peripheral edema. The most common laboratory abnormalities detected, in 10% or more of patients, were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

Xofigo comes in a solution and is administered at 4-week intervals for six injection cycles; it is slowly administered intravenously over 1 minute. Safety and efficacy of more than six injections has not been studied, according to the prescribing information.

emechcatie@frontlinemedcom.com

Radium-223 dichloride, an alpha-particle–emitting radioactive agent, has been approved for treating men with castration-resistant prostate cancer that has spread to the bones, the Food and Drug Administration announced on May 15.

The agent "binds with minerals in the bone to deliver radiation directly to bone tumors," Dr. Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, noted in the statement.

Ra-223 is the second drug for prostate cancer approved by the FDA in the last year that has been shown to extend the survival of men with metastatic prostate cancer, Dr. Pazdur noted. Enzalutamide (Xtandi), an androgen receptor inhibitor, was approved in August 2012 for treating men with metastatic castration-resistant prostate cancer who were previously treated with docetaxel.

Approval of the radium-223 treatment, which will be marketed as Xofigo by Bayer Pharmaceuticals, was based on a phase III study of men with symptomatic castration-resistant prostate cancer with symptomatic bone metastases, and no other metastases, randomized to treatment with radium 233 (541 men) every 4 weeks for six cycles or placebo (268 men). All patients received best standard of care, which included external-beam radiation therapy, corticosteroids, antiandrogens, estrogens, estramustine, or ketoconazole.

In an interim analysis, overall survival, the primary endpoint, was a median of 14 months among those in the radiotherapy arm, compared with 11.2 months among those on placebo, a highly statistically significant improvement, with a hazard ratio of 0.695. An updated exploratory analysis conducted later in the trial "confirmed Xofigo’s ability to extend overall survival," the FDA statement noted.

(The prescribing information states that in the updated analysis, median survival was 14.9 months vs. 11.3 months among those on placebo, with a hazard ratio of 0.695).

The most common side effects reported during clinical trials in men receiving the treatment, in 10% or more of patients, were nausea, diarrhea, vomiting and peripheral edema. The most common laboratory abnormalities detected, in 10% or more of patients, were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

Xofigo comes in a solution and is administered at 4-week intervals for six injection cycles; it is slowly administered intravenously over 1 minute. Safety and efficacy of more than six injections has not been studied, according to the prescribing information.

emechcatie@frontlinemedcom.com

SAN DIEGO – The number of urologists practicing in the United States is expected to decrease by 29% between 2009 and 2025, according to a new analysis.

"It’s one thing if the demand for urologists is going up and the supply is stable, but to have the demand go up and the supply almost falling off of a cliff is worrisome," Dr. Raj S. Pruthi said in an interview at the annual meeting of the American Urological Association. "The people who will be hardest hit by this are ones who already struggle with access: those who live in rural communities."

Dr. Pruthi and his colleagues used stock and flow models, starting with the supply of urologists in 2009. They added new entrants from the graduate medical education (GME) pipeline and subtracted attrition from training and from the workforce due to retirement or breaks from practice. The forecast model estimates a 29% head count reduction and a 25% decrease in the full-time equivalent (FTE) supply of urologists between 2009 and 2025. The projected decrease is more than four times greater than the Health Resources and Services Administration’s Physician Supply Model, which estimated a 7% decrease over the same time period.

Dr. Pruthi warned that none of the proposed changes to GME (recommendations from the Council of Graduate Medical Education’s 16th report or a recent proposal to Congress) will increase GME enough to offset the projected decline in head count. "GME funding has been capped since 1996," he said. "We’re setting forth a recipe for a very big problem that we’re going to have for future generations in terms of who’s going to take care of" a rapidly aging population.

As the Affordable Health Care Act takes shape, "one thing that’s not been considered adequately is physician supply," added Dr. Pruthi, chief of urologic surgery at the University of North Carolina at Chapel Hill. "Are there enough of us to help care for the population? That needs to be part of the calculus. We need to do efficient, appropriate care. We need to cut health care costs, but we have to remember our physician supply."

The shrinking number of urologists could affect mortality rates, as research has demonstrated an association between a higher density of urologists in a defined area and lower mortality from prostate, bladder, and kidney cancer. "As supply contracts, rural areas are likely to have an even greater loss of urologic surgeons since these areas have a higher percentage of surgeons closer to retirement age than urban areas," the researchers noted in their abstract. "The result may decrease access to screening, medical and surgical treatment for urologic conditions."

Dr. Pruthi acknowledged that the ability to predict physician demand is an imprecise science. However, "there is indirect data to suggest that our demand isn’t going to go away. It’s only going to go up with that rising incidence and with the rising number of aging baby boomers. Second, we don’t know the appropriate ratio of supply and demand. If you have limited supply, you have limited access. Is our culture accepting of that? Some of these limitations to access may have health consequences."

He and his associates plan to conduct more detailed work on the projection model, including the impact of increasing numbers of women entering the urology field. "About 5% of urologists are female, but in current residency matching the numbers are about 25% female," he said. "What impact will that have? We don’t know yet."

Dr. Pruthi said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – The number of urologists practicing in the United States is expected to decrease by 29% between 2009 and 2025, according to a new analysis.

"It’s one thing if the demand for urologists is going up and the supply is stable, but to have the demand go up and the supply almost falling off of a cliff is worrisome," Dr. Raj S. Pruthi said in an interview at the annual meeting of the American Urological Association. "The people who will be hardest hit by this are ones who already struggle with access: those who live in rural communities."

Dr. Pruthi and his colleagues used stock and flow models, starting with the supply of urologists in 2009. They added new entrants from the graduate medical education (GME) pipeline and subtracted attrition from training and from the workforce due to retirement or breaks from practice. The forecast model estimates a 29% head count reduction and a 25% decrease in the full-time equivalent (FTE) supply of urologists between 2009 and 2025. The projected decrease is more than four times greater than the Health Resources and Services Administration’s Physician Supply Model, which estimated a 7% decrease over the same time period.

Dr. Pruthi warned that none of the proposed changes to GME (recommendations from the Council of Graduate Medical Education’s 16th report or a recent proposal to Congress) will increase GME enough to offset the projected decline in head count. "GME funding has been capped since 1996," he said. "We’re setting forth a recipe for a very big problem that we’re going to have for future generations in terms of who’s going to take care of" a rapidly aging population.

As the Affordable Health Care Act takes shape, "one thing that’s not been considered adequately is physician supply," added Dr. Pruthi, chief of urologic surgery at the University of North Carolina at Chapel Hill. "Are there enough of us to help care for the population? That needs to be part of the calculus. We need to do efficient, appropriate care. We need to cut health care costs, but we have to remember our physician supply."

The shrinking number of urologists could affect mortality rates, as research has demonstrated an association between a higher density of urologists in a defined area and lower mortality from prostate, bladder, and kidney cancer. "As supply contracts, rural areas are likely to have an even greater loss of urologic surgeons since these areas have a higher percentage of surgeons closer to retirement age than urban areas," the researchers noted in their abstract. "The result may decrease access to screening, medical and surgical treatment for urologic conditions."

Dr. Pruthi acknowledged that the ability to predict physician demand is an imprecise science. However, "there is indirect data to suggest that our demand isn’t going to go away. It’s only going to go up with that rising incidence and with the rising number of aging baby boomers. Second, we don’t know the appropriate ratio of supply and demand. If you have limited supply, you have limited access. Is our culture accepting of that? Some of these limitations to access may have health consequences."

He and his associates plan to conduct more detailed work on the projection model, including the impact of increasing numbers of women entering the urology field. "About 5% of urologists are female, but in current residency matching the numbers are about 25% female," he said. "What impact will that have? We don’t know yet."

Dr. Pruthi said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com

SAN DIEGO – The number of urologists practicing in the United States is expected to decrease by 29% between 2009 and 2025, according to a new analysis.

"It’s one thing if the demand for urologists is going up and the supply is stable, but to have the demand go up and the supply almost falling off of a cliff is worrisome," Dr. Raj S. Pruthi said in an interview at the annual meeting of the American Urological Association. "The people who will be hardest hit by this are ones who already struggle with access: those who live in rural communities."

Dr. Pruthi and his colleagues used stock and flow models, starting with the supply of urologists in 2009. They added new entrants from the graduate medical education (GME) pipeline and subtracted attrition from training and from the workforce due to retirement or breaks from practice. The forecast model estimates a 29% head count reduction and a 25% decrease in the full-time equivalent (FTE) supply of urologists between 2009 and 2025. The projected decrease is more than four times greater than the Health Resources and Services Administration’s Physician Supply Model, which estimated a 7% decrease over the same time period.

Dr. Pruthi warned that none of the proposed changes to GME (recommendations from the Council of Graduate Medical Education’s 16th report or a recent proposal to Congress) will increase GME enough to offset the projected decline in head count. "GME funding has been capped since 1996," he said. "We’re setting forth a recipe for a very big problem that we’re going to have for future generations in terms of who’s going to take care of" a rapidly aging population.

As the Affordable Health Care Act takes shape, "one thing that’s not been considered adequately is physician supply," added Dr. Pruthi, chief of urologic surgery at the University of North Carolina at Chapel Hill. "Are there enough of us to help care for the population? That needs to be part of the calculus. We need to do efficient, appropriate care. We need to cut health care costs, but we have to remember our physician supply."

The shrinking number of urologists could affect mortality rates, as research has demonstrated an association between a higher density of urologists in a defined area and lower mortality from prostate, bladder, and kidney cancer. "As supply contracts, rural areas are likely to have an even greater loss of urologic surgeons since these areas have a higher percentage of surgeons closer to retirement age than urban areas," the researchers noted in their abstract. "The result may decrease access to screening, medical and surgical treatment for urologic conditions."

Dr. Pruthi acknowledged that the ability to predict physician demand is an imprecise science. However, "there is indirect data to suggest that our demand isn’t going to go away. It’s only going to go up with that rising incidence and with the rising number of aging baby boomers. Second, we don’t know the appropriate ratio of supply and demand. If you have limited supply, you have limited access. Is our culture accepting of that? Some of these limitations to access may have health consequences."

He and his associates plan to conduct more detailed work on the projection model, including the impact of increasing numbers of women entering the urology field. "About 5% of urologists are female, but in current residency matching the numbers are about 25% female," he said. "What impact will that have? We don’t know yet."

Dr. Pruthi said that he had no relevant financial conflicts to disclose.

dbrunk@frontlinemedcom.com