NRG-GU006

A Phase II, Double-Blinded, Placebo-Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti-Androgen Therapy with Apalutamide in Recurrent Prostate Cancer

Principal Investigator

Felix Feng, MD

Status

Disease Site

Genitourinary [GU] Prostate

Phase

II

Developmental Therapeutics

No

Primary Objective

To determine whether, in men with post-prostatectomy PSA recurrences, salvage radiation (SRT) with enhanced anti-androgen therapy with apalutamide will improve biochemical progression-free survival (bPFS) compared to SRT alone. A bPFS event is defined as a rise in PSA > 0.2 ng/mL from nadir, confirmed by a second PSA measurement; clinical or radiographic local, regional, or distant metastases; or death from any cause, whichever occurs first.  

Patient Population

Patients with pathologically (histologically) proven diagnosis of prostate adenocarcinoma. Prostatectomy must have been performed within 10 years prior to Step 1 registration and any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted.

Target Accrual

324