A Trial to See What the Results Are for Radiation Therapy and Hormone Therapy vs Radiation Therapy With Enhanced Hormone Therapy With Enzalutamide for Patients With PSA Recurrence After Surgery

Official Title

STEEL: A Randomized Phase II Trial of Salvage Radiation Therapy With Standard vs Enhanced Androgen Deprivation Therapy (With Enzalutamide) in Patients With Post-Prostatectomy PSA Recurrences With Aggressive Disease Features

Summary:

Patients with post-prostatectomy PSA (Prostate Specific Antigen) recurrences with aggressive disease features will receive salvage radiation therapy and standard androgen deprivation therapy (ADT) or enhanced ADT to determine if there is any improvement in progression-free survival when enhanced ADT is used compared to standard ADT.

Trial Description

Primary Outcome:

• Progression-Free Survival (PFS)

• To determine whether, in men with post-prostatectomy PSA (prostate specific antigen) recurrences with aggressive disease features, salvage radiation therapy (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.

View this trial on ClinicalTrials.gov