SWOG 1216: A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer
Purpose: The purpose of this study is to compare overall survival in newly diagnosed metastatic prostate cancer patients randomly assigned to androgen deprivation therapy (ADT) + TAK-700 versus ADT + bicalutamide.
January 01, 1900
Cancer () - Prostate
Gary Goodman, M.D.
Swedish Cancer Institute
- Clinical diagnosis of metastatic prostate cancer
- PSA ≥ 2 ng/mL within 90 days prior to initiation of androgen deprivation. therapy (for early induction) or prior to registration (for late induction)
- No more than 36 months of prior neoadjuvant and/or adjuvant hormonal therapy.
- No ≥ 6 months since completion of androgen deprivation therapy
- No prior or concurrent therapy with ketoconazole, aminoglutethimide or abiraterone acetate, or enzalutamide (MDV3100). Concurrent megestrol for hot flashes is allowed
- No chemotherapy for treatment of metastatic prostate cancer. Prior chemotherapy in the neoadjuvant or adjuvant setting is allowed
- No ≥ 2 years since completion of chemotherapy in the neoadjuvant or adjuvant setting
- No ≥ 30 days since prior medical castration for metastatic prostate cancer
- No prior bilateral orchiectomy