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Brief Title Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy
Official Title Phase II Randomized Placebo-Controlled Double-Blind Study of Salvage Radiation Therapy (SRT) Plus Placebo Versus SRT Plus Enzalutamide in Men With High-Risk PSA-Recurrent Prostate Cancer After Radical Prostatectomy
Principal Investigator Liauw, Stanley
Brief Summary The primary hypothesis of this study is that outcomes for patients with biochemically recurrent prostate cancer following radical prostatectomy will be improved by the addition of enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for further study in the definitive phase III setting. This study builds on the prior success of high-dose bicalutamide (for 24 months) when combined with salvage external radiation therapy (XRT), while using a newer more potent anti-androgen for a shorter duration of time (6 months) in an effort to minimize adverse effects.
Gender Male
Ages 18 Years
Enrollment 122
Accepts Healthy Volunteers No
Lead Sponsor Sidney Kimmel Comprehensive Cancer CenterOther
Collaborator Astellas Pharma IncIndustry
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Study Phase Phase 2
Study Type Interventional
Contact Name Charles Drake, M.D.
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Adenocarcinoma of the Prostate
Detail for Health Professional (on
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