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
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