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PROSTVAC Phase 3 Clinical Study

PROSPECT was a global, randomized, double-blind, placebo-controlled phase 3 study conducted under a Special Protocol Assessment (SPA) from the FDA. The objective of the study was 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, castration-resistant prostate cancer (mCRPC). 

Study design

Men with non/minimally symptomatic mCRPC (n=1297)  PROSTVAC  Long-term follow up  SURVIVAL 
PROSTVAC + GM-CSF
Placebo

5 Months Treatment


By January 2015, the study had been fully enrolled with 1,297 asymptomatic or minimally symptomatic mCRPC patients. Patients were enrolled at more than 200 sites in 15 countries, including Australia, Belgium, Canada, Denmark, Estonia, France, Germany, Iceland, Israel, Netherlands, Poland, Russia, Spain, United Kingdom and the United States.

In September 2017, an independent Data Monitoring Committee (DMC) determined, based on a preplanned interim analysis, that continuation of the Phase 3 PROSPECT study of PROSTVAC® in patients with metastatic castration-resistant prostate cancer (mCRPC) was futile.