Return to Clinical Trials Search Results

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

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 greater than 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. Secondary Objectives To assess whether molecular stratification by the PAM50 gene expression clustering will identify subsets of prostate cancer (Luminal A or Basal, Luminal B) which derive the greatest benefit from anti-androgen therapy (PAM50 test will be run in conjunction with the commercial Decipher test from GenomeDx). To assess overall survival To assess cancer-specific mortality To assess metastasis-free survival To assess distant metastasis To assess local-regional progression To assess PSA nadir during first year of treatment and prior to initiation of any hormonal salvage therapy To assess initiation of salvage hormonal therapy To assess PSA with a non-castrate testosterone at 1 and 3 years post randomization: PSA less than 0.1 ng/ml and testosterone greater than or equal to 50 ng/dl To assess acute and late physician-reported morbidity (per the CTCAE version 4.0) after SRT +/- apalutamide; To assess acute and late patient-reported symptomatic adverse events morbidity (per the PRO-CTCAE) after SRT +/- apalutamide. To assess testosterone levels at 3, 6, 9, 12, and 36 months post randomization.

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 greater than 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. Secondary Objectives To assess whether molecular stratification by the PAM50 gene expression clustering will identify subsets of prostate cancer (Luminal A or Basal, Luminal B) which derive the greatest benefit from anti-androgen therapy (PAM50 test will be run in conjunction with the commercial Decipher test from GenomeDx). To assess overall survival To assess cancer-specific mortality To assess metastasis-free survival To assess distant metastasis To assess local-regional progression To assess PSA nadir during first year of treatment and prior to initiation of any hormonal salvage therapy To assess initiation of salvage hormonal therapy To assess PSA with a non-castrate testosterone at 1 and 3 years post randomization: PSA less than 0.1 ng/ml and testosterone greater than or equal to 50 ng/dl To assess acute and late physician-reported morbidity (per the CTCAE version 4.0) after SRT +/- apalutamide; To assess acute and late patient-reported symptomatic adverse events morbidity (per the PRO-CTCAE) after SRT +/- apalutamide. To assess testosterone levels at 3, 6, 9, 12, and 36 months post randomization.