S1216 A Phase III Randomized Trial Comparing Androgen Deprivation Therapy TAK-700 With Androgen Deprivation Therapy Bicalutamide in Patients With Newly Diagnosed Metastatic Hormone Sensitive Prostate Cancer
Sibley Memorial Hospital
Johns Hopkins Kimmel Cancer Center in Baltimore
This research is being done to find out what effects (good and/or bad) there are to adding the new investigational drug TAK-700 (also called orteronel) to standard hormone therapy which is used to treat prostate cancer as compared to the standard of hormone therapy alone.
Adult men with prostate cancer that has spread and are beginning hormone therapy may be eligible. Additional eligibility requirements include: *PSA greater than equal to 2 ng/mL within 90 days; *Does not have brain metastases; *Has not received chemotherapy for metastatic prostate cancer; *If hormone therapy was started, it was within 30 days of study registration; *If received hormone therapy in the neoadjuvant or adjuvant setting, it was no longer than 3 years and it's been 2 years since completing the therapy; *Has not undergone a bilateral orchiectomy; *Does not have cardiac disease or uncontrolled hypertension; *Has normal lab test results; *Does not have HIV, Hepatitis B or C or other life-threatening illness; and *Is able to swallow pills.
Men with newly diagnosed metastatic prostate cancer with a PSA of 2 ng/ml or more may be considered for this study. Interested candidates will review and sign a consent form desribing the research study and then, will be screened to make sure they are eligible to participate. Eligible participants will be randomized to receive TAK-700 or Bicalutamide. All participants will receive hormone therapy. All agents are taken by mouth each day until your disease progresses or you are no longer able to tolerate taking them. We will routinely check your PSA. After you stop the study regimen, we would like to keep in touch with you for 10 years to see how you are doing.
05/25/2016 05:03 AM