Prostate Cancer Metastatic Clinical Trial
Official title:
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
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.
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:
1. (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF
2. (Arm V) PROSTVAC-V/F plus GM-CSF placebo
3. (Arm P) Double placebo
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