Genitourinary Cancer

Objectives: This randomized, open-label phase III non-inferiority trial compares 20 mg/m2 and 25 mg/m2 doses of cabazitaxel (Jevtana). It seeks to determine whether the lower dose may be better tolerated without reducing the benefit in overall and progression-free survival.

Key entry or exclusion criteria: Patients must be resistant to hormone therapy and previously treated with docetaxel (Taxotere). Men previously treated with cabazitaxel or mitoxantrone (Novantrone) are excluded.

Locations: 172 sites.

Goal: 1,200 patients.

Study sponsor: Sanofi-Aventis

Link for more information: clinicaltrials.gov/ct2/show/NCT01308580

NIH clinical trials identifier: NCT01308580

Objectives: This randomized, open-label phase III non-inferiority trial compares 20 mg/m2 and 25 mg/m2 doses of cabazitaxel (Jevtana). It seeks to determine whether the lower dose may be better tolerated without reducing the benefit in overall and progression-free survival.

Key entry or exclusion criteria: Patients must be resistant to hormone therapy and previously treated with docetaxel (Taxotere). Men previously treated with cabazitaxel or mitoxantrone (Novantrone) are excluded.

Locations: 172 sites.

Goal: 1,200 patients.

Study sponsor: Sanofi-Aventis

Link for more information: clinicaltrials.gov/ct2/show/NCT01308580

NIH clinical trials identifier: NCT01308580

Objectives: This randomized, open-label phase III non-inferiority trial compares 20 mg/m2 and 25 mg/m2 doses of cabazitaxel (Jevtana). It seeks to determine whether the lower dose may be better tolerated without reducing the benefit in overall and progression-free survival.

Key entry or exclusion criteria: Patients must be resistant to hormone therapy and previously treated with docetaxel (Taxotere). Men previously treated with cabazitaxel or mitoxantrone (Novantrone) are excluded.

Locations: 172 sites.

Goal: 1,200 patients.

Study sponsor: Sanofi-Aventis

Link for more information: clinicaltrials.gov/ct2/show/NCT01308580

NIH clinical trials identifier: NCT01308580

Objectives: Cabazitaxel (Jevtana) is approved for second-line treatment of metastatic prostate cancer in patients previously treated with docetaxel (Taxotere). This randomized phase III trial pits the two taxanes against each other in the first-line setting. Two doses of cabazitaxel (20 mg/m2 and 25 mg/m2) are explored; overall survival is the primary outcome.

Key entry or exclusion criteria: Patients with prior chemotherapy for prostate cancer are excluded.

Locations: 166 sites.

Goal: 1,170 patients.

Study sponsor: Sanofi-Aventis

Link for more information: clinicaltrials.gov/ct2/show/NCT01308567

NIH clinical trials identifier: NCT01308567

Objectives: Cabazitaxel (Jevtana) is approved for second-line treatment of metastatic prostate cancer in patients previously treated with docetaxel (Taxotere). This randomized phase III trial pits the two taxanes against each other in the first-line setting. Two doses of cabazitaxel (20 mg/m2 and 25 mg/m2) are explored; overall survival is the primary outcome.

Key entry or exclusion criteria: Patients with prior chemotherapy for prostate cancer are excluded.

Locations: 166 sites.

Goal: 1,170 patients.

Study sponsor: Sanofi-Aventis

Link for more information: clinicaltrials.gov/ct2/show/NCT01308567

NIH clinical trials identifier: NCT01308567

Objectives: Cabazitaxel (Jevtana) is approved for second-line treatment of metastatic prostate cancer in patients previously treated with docetaxel (Taxotere). This randomized phase III trial pits the two taxanes against each other in the first-line setting. Two doses of cabazitaxel (20 mg/m2 and 25 mg/m2) are explored; overall survival is the primary outcome.

Key entry or exclusion criteria: Patients with prior chemotherapy for prostate cancer are excluded.

Locations: 166 sites.

Goal: 1,170 patients.

Study sponsor: Sanofi-Aventis

Link for more information: clinicaltrials.gov/ct2/show/NCT01308567

NIH clinical trials identifier: NCT01308567

Objectives: Custirsen (OGX-011), a novel inhibitor of testosterone-repressed prostate message-2 (TRPM-2), sensitizes cells to chemotherapy. This randomized, open-label, phase III trial is designed to confirm that adding it to standard first-line treatment with docetaxel (Taxotere) and prednisone can slow tumor progression and improve overall survival.

Key entry or exclusion criteria: Patients must have evidence of progression, and be willing to continue primary androgen suppression throughout the study, unless treated with bilateral orchiectomy. Men who received any other cytotoxic chemotherapy as treatment for prostate cancer are excluded.

Locations: 140 sites.

Goal: 1,000 patients.

Study sponsor: Teva Pharmaceutical Industries in collaboration with OncoGenex Technologies.

Link for more information: clinicaltrials.gov/ct2/show/NCT01188187

NIH clinical trials identifier: NCT01188187

Objectives: Custirsen (OGX-011), a novel inhibitor of testosterone-repressed prostate message-2 (TRPM-2), sensitizes cells to chemotherapy. This randomized, open-label, phase III trial is designed to confirm that adding it to standard first-line treatment with docetaxel (Taxotere) and prednisone can slow tumor progression and improve overall survival.

Key entry or exclusion criteria: Patients must have evidence of progression, and be willing to continue primary androgen suppression throughout the study, unless treated with bilateral orchiectomy. Men who received any other cytotoxic chemotherapy as treatment for prostate cancer are excluded.

Locations: 140 sites.

Goal: 1,000 patients.

Study sponsor: Teva Pharmaceutical Industries in collaboration with OncoGenex Technologies.

Link for more information: clinicaltrials.gov/ct2/show/NCT01188187

NIH clinical trials identifier: NCT01188187

Objectives: Custirsen (OGX-011), a novel inhibitor of testosterone-repressed prostate message-2 (TRPM-2), sensitizes cells to chemotherapy. This randomized, open-label, phase III trial is designed to confirm that adding it to standard first-line treatment with docetaxel (Taxotere) and prednisone can slow tumor progression and improve overall survival.

Key entry or exclusion criteria: Patients must have evidence of progression, and be willing to continue primary androgen suppression throughout the study, unless treated with bilateral orchiectomy. Men who received any other cytotoxic chemotherapy as treatment for prostate cancer are excluded.

Locations: 140 sites.

Goal: 1,000 patients.

Study sponsor: Teva Pharmaceutical Industries in collaboration with OncoGenex Technologies.

Link for more information: clinicaltrials.gov/ct2/show/NCT01188187

NIH clinical trials identifier: NCT01188187

Objectives: This phase III trial asks whether third-line cabozantinib, a novel oral multi-targeted tyrosine kinase inhibitor, can improve pain and bone scan responses compared with mitoxantrone (Novantrone) plus prednisone.

Key entry or exclusion criteria: Patients must have received prior docetaxel (Taxotere) plus either abiraterone (Zytiga) or MDV3100 (enzalutamide) treatment, and bone metastases that require opioid narcotic intervention for pain.

Locations: 20 sites.

Goal: 246 patients.

Study sponsor: Exelixis

Link for more information: clinicaltrials.gov/ct2/show/NCT01522443

NIH clinical trials identifier: NCT01522443

Objectives: This phase III trial asks whether third-line cabozantinib, a novel oral multi-targeted tyrosine kinase inhibitor, can improve pain and bone scan responses compared with mitoxantrone (Novantrone) plus prednisone.

Key entry or exclusion criteria: Patients must have received prior docetaxel (Taxotere) plus either abiraterone (Zytiga) or MDV3100 (enzalutamide) treatment, and bone metastases that require opioid narcotic intervention for pain.

Locations: 20 sites.

Goal: 246 patients.

Study sponsor: Exelixis

Link for more information: clinicaltrials.gov/ct2/show/NCT01522443

NIH clinical trials identifier: NCT01522443

Objectives: This phase III trial asks whether third-line cabozantinib, a novel oral multi-targeted tyrosine kinase inhibitor, can improve pain and bone scan responses compared with mitoxantrone (Novantrone) plus prednisone.

Key entry or exclusion criteria: Patients must have received prior docetaxel (Taxotere) plus either abiraterone (Zytiga) or MDV3100 (enzalutamide) treatment, and bone metastases that require opioid narcotic intervention for pain.

Locations: 20 sites.

Goal: 246 patients.

Study sponsor: Exelixis

Link for more information: clinicaltrials.gov/ct2/show/NCT01522443

NIH clinical trials identifier: NCT01522443

Objectives: This phase III trial asks whether third-line cabozantinib, a novel oral multi-targeted tyrosine kinase inhibitor, can improve overall survival compared with prednisone after treatment failures with leading approved and novel therapies.

Key entry or exclusion criteria: Patients must have received prior docetaxel (Taxotere) plus either abiraterone (Zytiga) or enzalutamide (Xtandi, MDV3100) treatment, and have evidence of prostate cancer progression on each agent independently.

Locations: 10 sites.

Goal: 960 patients.

Study sponsor: Exelixis

Link for more information: clinicaltrials.gov/ct2/show/NCT01605227

NIH clinical trials identifier: NCT01605227

Objectives: This phase III trial asks whether third-line cabozantinib, a novel oral multi-targeted tyrosine kinase inhibitor, can improve overall survival compared with prednisone after treatment failures with leading approved and novel therapies.

Key entry or exclusion criteria: Patients must have received prior docetaxel (Taxotere) plus either abiraterone (Zytiga) or enzalutamide (Xtandi, MDV3100) treatment, and have evidence of prostate cancer progression on each agent independently.

Locations: 10 sites.

Goal: 960 patients.

Study sponsor: Exelixis

Link for more information: clinicaltrials.gov/ct2/show/NCT01605227

NIH clinical trials identifier: NCT01605227

Objectives: This phase III trial asks whether third-line cabozantinib, a novel oral multi-targeted tyrosine kinase inhibitor, can improve overall survival compared with prednisone after treatment failures with leading approved and novel therapies.

Key entry or exclusion criteria: Patients must have received prior docetaxel (Taxotere) plus either abiraterone (Zytiga) or enzalutamide (Xtandi, MDV3100) treatment, and have evidence of prostate cancer progression on each agent independently.

Locations: 10 sites.

Goal: 960 patients.

Study sponsor: Exelixis

Link for more information: clinicaltrials.gov/ct2/show/NCT01605227

NIH clinical trials identifier: NCT01605227

Objectives: This randomized phase III trial asks whether a "MEAL program intervention," including dietary education and telephone counseling sessions over 24 months, can alter disease progression when compared with information on standard U.S. Dietary Guidelines.

Key entry or exclusion criteria: Patients should be 50-80 years of age with biopsy-proven disease up to clinical stage T2a and no distant metastases.

Locations: 120 sites.

Goal: 464 patients.

Study sponsor: Cancer and Leukemia Group B in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT01238172

NIH clinical trials identifier: NCT01238172

Objectives: This randomized phase III trial asks whether a "MEAL program intervention," including dietary education and telephone counseling sessions over 24 months, can alter disease progression when compared with information on standard U.S. Dietary Guidelines.

Key entry or exclusion criteria: Patients should be 50-80 years of age with biopsy-proven disease up to clinical stage T2a and no distant metastases.

Locations: 120 sites.

Goal: 464 patients.

Study sponsor: Cancer and Leukemia Group B in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT01238172

NIH clinical trials identifier: NCT01238172

Objectives: This randomized phase III trial asks whether a "MEAL program intervention," including dietary education and telephone counseling sessions over 24 months, can alter disease progression when compared with information on standard U.S. Dietary Guidelines.

Key entry or exclusion criteria: Patients should be 50-80 years of age with biopsy-proven disease up to clinical stage T2a and no distant metastases.

Locations: 120 sites.

Goal: 464 patients.

Study sponsor: Cancer and Leukemia Group B in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT01238172

NIH clinical trials identifier: NCT01238172

Objectives: This randomized phase III trial has three arms. The control group receives prostate bed radiotherapy (PBRT) alone after surgery. In one experimental arm, men receive PBRT, short-term androgen-deprivation therapy, and pelvic lymph node radiation therapy; in another they are given PBRT and short-term androgen-deprivation therapy without pelvic lymph node radiation therapy. Freedom from disease progression is the primary outcome measure.

Key entry or exclusion criteria: Lymph node dissection is not required but patients known to have positive nodes are not eligible.

Locations: 438 sites.

Goal: 1,764 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT00567580

NIH clinical trials identifier: NCT00567580

Objectives: This randomized phase III trial has three arms. The control group receives prostate bed radiotherapy (PBRT) alone after surgery. In one experimental arm, men receive PBRT, short-term androgen-deprivation therapy, and pelvic lymph node radiation therapy; in another they are given PBRT and short-term androgen-deprivation therapy without pelvic lymph node radiation therapy. Freedom from disease progression is the primary outcome measure.

Key entry or exclusion criteria: Lymph node dissection is not required but patients known to have positive nodes are not eligible.

Locations: 438 sites.

Goal: 1,764 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT00567580

NIH clinical trials identifier: NCT00567580

Objectives: This randomized phase III trial has three arms. The control group receives prostate bed radiotherapy (PBRT) alone after surgery. In one experimental arm, men receive PBRT, short-term androgen-deprivation therapy, and pelvic lymph node radiation therapy; in another they are given PBRT and short-term androgen-deprivation therapy without pelvic lymph node radiation therapy. Freedom from disease progression is the primary outcome measure.

Key entry or exclusion criteria: Lymph node dissection is not required but patients known to have positive nodes are not eligible.

Locations: 438 sites.

Goal: 1,764 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT00567580

NIH clinical trials identifier: NCT00567580

Objectives: This trial considers whether prophylactic, neoadjuvant, androgen-deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) can improve overall survival as compared with NADT and high-dose prostate and seminal vesicle radiation therapy that is given either as intensity-modulated radiation therapy or as external-beam radiation therapy at either a high-dose rate or with a permanent prostate (radioactive seed) implant boost.

Key entry or exclusion criteria: Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration in patients at moderate- to high-risk for recurrence along with clinically negative lymph nodes within 90 days prior and no evidence of bone metastases within 120 days prior.

Locations: 150 sites.

Goal: 2,580 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT01368588

NIH clinical trials identifier: NCT01368588

Objectives: This trial considers whether prophylactic, neoadjuvant, androgen-deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) can improve overall survival as compared with NADT and high-dose prostate and seminal vesicle radiation therapy that is given either as intensity-modulated radiation therapy or as external-beam radiation therapy at either a high-dose rate or with a permanent prostate (radioactive seed) implant boost.

Key entry or exclusion criteria: Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration in patients at moderate- to high-risk for recurrence along with clinically negative lymph nodes within 90 days prior and no evidence of bone metastases within 120 days prior.

Locations: 150 sites.

Goal: 2,580 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT01368588

NIH clinical trials identifier: NCT01368588

Objectives: This trial considers whether prophylactic, neoadjuvant, androgen-deprivation therapy (NADT) and whole-pelvic radiation therapy (WPRT) can improve overall survival as compared with NADT and high-dose prostate and seminal vesicle radiation therapy that is given either as intensity-modulated radiation therapy or as external-beam radiation therapy at either a high-dose rate or with a permanent prostate (radioactive seed) implant boost.

Key entry or exclusion criteria: Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration in patients at moderate- to high-risk for recurrence along with clinically negative lymph nodes within 90 days prior and no evidence of bone metastases within 120 days prior.

Locations: 150 sites.

Goal: 2,580 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT01368588

NIH clinical trials identifier: NCT01368588

Objectives: This randomized phase III trial asks whether dose-escalated radiation therapy would be more effective if given concurrently with short-term androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide, goserelin, buserelin, or triptorelin). Overall survival is the primary end point.

Key entry or exclusion criteria: Patients should have histologically confirmed adenocarcinoma of the prostate diagnosed within the past 180 days and be at intermediate-risk for recurrence. Lymph nodes should be clinically negative with no evidence of bone metastases on a bone scan within the past 60 days.

Locations: 263 sites.

Goal: 1,520 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT00936390

NIH clinical trials identifier: NCT00936390

Objectives: This randomized phase III trial asks whether dose-escalated radiation therapy would be more effective if given concurrently with short-term androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide, goserelin, buserelin, or triptorelin). Overall survival is the primary end point.

Key entry or exclusion criteria: Patients should have histologically confirmed adenocarcinoma of the prostate diagnosed within the past 180 days and be at intermediate-risk for recurrence. Lymph nodes should be clinically negative with no evidence of bone metastases on a bone scan within the past 60 days.

Locations: 263 sites.

Goal: 1,520 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT00936390

NIH clinical trials identifier: NCT00936390

Objectives: This randomized phase III trial asks whether dose-escalated radiation therapy would be more effective if given concurrently with short-term androgen-deprivation therapy comprising luteinizing-hormone releasing-hormone (LHRH) agonist (leuprolide, goserelin, buserelin, or triptorelin). Overall survival is the primary end point.

Key entry or exclusion criteria: Patients should have histologically confirmed adenocarcinoma of the prostate diagnosed within the past 180 days and be at intermediate-risk for recurrence. Lymph nodes should be clinically negative with no evidence of bone metastases on a bone scan within the past 60 days.

Locations: 263 sites.

Goal: 1,520 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT00936390

NIH clinical trials identifier: NCT00936390

Objectives: Novel TAK-700, also known as orteronel, reduces androgen production by inhibiting the steroid 17alpha-monooxygenase in the testes and adrenal glands. This randomized phase III trial asks whether adding orteronel to hormone therapy and radiation therapy can improve overall survival.

Key entry or exclusion criteria: Patients must have histologically confirmed adenocarcinoma of the prostate with a Gleason score of 7 or higher. Lymph nodes should be negative with no evidence of distant metastases within 90 days of entering the trial.

Locations: 24 sites.

Goal: 900 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT01546987

NIH clinical trials identifier: NCT01546987

Objectives: Novel TAK-700, also known as orteronel, reduces androgen production by inhibiting the steroid 17alpha-monooxygenase in the testes and adrenal glands. This randomized phase III trial asks whether adding orteronel to hormone therapy and radiation therapy can improve overall survival.

Key entry or exclusion criteria: Patients must have histologically confirmed adenocarcinoma of the prostate with a Gleason score of 7 or higher. Lymph nodes should be negative with no evidence of distant metastases within 90 days of entering the trial.

Locations: 24 sites.

Goal: 900 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT01546987

NIH clinical trials identifier: NCT01546987

Objectives: Novel TAK-700, also known as orteronel, reduces androgen production by inhibiting the steroid 17alpha-monooxygenase in the testes and adrenal glands. This randomized phase III trial asks whether adding orteronel to hormone therapy and radiation therapy can improve overall survival.

Key entry or exclusion criteria: Patients must have histologically confirmed adenocarcinoma of the prostate with a Gleason score of 7 or higher. Lymph nodes should be negative with no evidence of distant metastases within 90 days of entering the trial.

Locations: 24 sites.

Goal: 900 patients.

Study sponsor: Radiation Therapy Oncology Group in collaboration with the National Cancer Institute.

Link for more information: clinicaltrials.gov/ct2/show/NCT01546987

NIH clinical trials identifier: NCT01546987