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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