5464S-13: S1216

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

Type of Study
Cancer (Oncology) - Prostate
Location
Swedish Cancer Institute
Short Description
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.
Status
Open to Enrollment
Principal Investigator
Gary Goodman, M.D.
Eligibility Notes
  • 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
More Info Link
Additional information about the study summary and eligibility criteria may be viewed on the U.S. National Institutes of Health (NIH) website.
Phone
(206) 215-3086
Email
CancerResearch@swedish.org