NCT01322490

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,297 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
BIOLOGICAL	PROSTVAC-V
BIOLOGICAL	PROSTVAC-F
DRUG	GM-CSF
OTHER	GM-CSF Placebo
BIOLOGICAL	Placebo	PROSTVAC V/F Placebo

Timeline

• Start date: 2011-11-28
• Primary completion: 2017-09-25
• Completion: 2017-12-15
• First posted: 2011-03-24
• Last updated: 2019-09-04
• Results posted: 2019-08-08

Locations

220 sites across 16 countries: United States, Australia, Belgium, Canada, Denmark, Estonia, France, Germany, Iceland, Israel, Netherlands, Poland, Puerto Rico, Russia, Spain, United Kingdom