Overview

Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy

Status:
Active, not recruiting
Trial end date:
2023-01-10
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators:
Astellas Pharma Inc
Medivation, Inc.