PROSPECT Phase 3 Clinical Study
PROSPECT is a global, randomized, double-blind, placebo-controlled phase 3 study being conducted under a Special Protocol Assessment (SPA) from the FDA. The objective of the 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, castration-resistant prostate cancer (mCRPC).
Design of the PROSPECT Clinical Study:
A Global, Double-Blind, Randomized Phase 3 Clinical Study
|Men with non/minimally symptomatic mCRPC (n=1200)||↗||PROSTVAC||↘||Long-term follow up||→||SURVIVAL|
|→||PROSTVAC + GM-CSF||→|
5 Months Treatment
PROSPECT is a global study expected to enroll 1200 asymptomatic or minimally symptomatic mCRPC patients at approximately 200 clinical study centers in up to 15 countries.
The PROSPECT study is active in more than 200 clinical study centers across Australia, Belgium, Canada, Denmark, Estonia, France, Germany, Iceland, Israel, Netherlands, Poland, Russia, Spain, United Kingdom and the United States.
Key requirements for study eligibility:
- Diagnosis of asymptomatic or minimally symptomatic mCRPC
- No prior treatment with chemotherapy
The primary endpoint is overall survival (OS); for the study outcome to be positive, either one or both of the treatment arms must demonstrate a statistically significant improvement in OS vs placebo.
The PROSPECT study statistical analysis plan, accepted by the FDA under the SPA, includes prespecified interim analyses of data to evaluate whether the study should continue as planned or potentially be stopped early, either for efficacy or futility. If the study exceeds the efficacy threshold during an interim analysis, applications for product marketing approval may be filed with regulatory authorities at an earlier stage, potentially shortening the overall development time.
Additional details of the study can be found on clinicaltrials.gov (NCT01322490).