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
Closed to Accrual
Date Opened To Accrual
April 27 2018
Date Closed to Accrual
May 19 2020
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.