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
The purpose of this study is to compare the overall survival of two groups of patients: those randomly assigned to get androgen deprivation therapy (ADT, in the form of leuprolide or goserelin acetate) plus TAK-700 (the study drug), and those who receive ADT plus bicalutamide (an anti-androgen). This study will compare how long it takes for participants in each group to progress (how long it takes for their cancer to spread), what kind of PSA response each group has, and side effects of both groups.
- Subjects must have confirmed adenocarcinoma of the prostate that has spread to other parts of their body, or “metastasized” (spread to bones, lymph nodes, etc; except cancer that has spread to the brain)
- Subjects must have adequate kidney and liver function
- Subjects must have not had hormonal therapy before, or if so, it must not have lasted more than 36 months and it must have finished greater than 6 months ago
- Subjects must not have had any chemotherapy for metastatic cancer
Age range 18+
18 - 150
Healthy Volunteers Needed
Duration of Participation
Duration of participation- Up to 10 years after you stop treatment or for the rest of your life, whichever occurs first.
Clinical trials information line: Phone 503-494-1080 or firstname.lastname@example.org
Southwest Oncology Group (SWOG) and Millennium Pharmaceuticals, Inc.