RTOG Foundation Study 3506

STEEL

A Randomized Phase II Trial of Salvage Radiotherapy with Standard vs. Enhanced Androgen Deprivation Therapy (with Enzalutamide) in Patients with Post-Prostatectomy PSA Recurrences with Aggressive Disease Features

Principal Investigators

Edwin Posadas, MD
Felix Feng, MD
Hiram Gay, MD

Primary Objective

The primary goal of this study is to determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, if salvage radiotherapy (SRT) with enhanced androgen deprivation therapy (ADT), consisting of enzalutamide (MDV3100) and a GnRH analog, will improve progression-free survival compared to SRT with standard GnRH analog-based ADT.

Patient Population

Post prostatectomy prostate cancer patients who have had a PSA recurrence and have signs of aggressive disease features, which include Gleason score of 8-10, seminal vesicle invasion, locoregional node involvement at radical prostatectomy.