BNIT-PRV-301 is a randomized, placebo-controlled, multi-center, global Phase 3 efficacy trial of PROSTVAC in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a 3-arm study and will evaluate overall survival in two separate comparisons, PROSTVAC plus adjuvant dose GM-CSF versus controls, and PROSTVAC without GM-CSF versus controls.~Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are:~(Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF~(Arm V) PROSTVAC-V/F plus GM-CSF placebo~(Arm P) Double placebo
The purpose of this study is to determine whether PROSTVAC alone or in combination with GM-CSF is effective in prolonging overall survival in men with few or no symptoms from metastatic, castrate-resistant prostate cancer.