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 (Prospect)
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.
Prostate Cancer Metastatic
Other: GM-CSF Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Overall survival [ Time Frame: Survival will be assessed over the life of the study ] [ Designated as safety issue: No ]Overall survival will be measured for all patients until the required number of events per comparison arm is reached.
- Proportion of event-free patients compared with placebo [ Time Frame: Events will be measured at baseline and 6 months ] [ Designated as safety issue: No ]This endpoint will measure the proportion of patients receiving PROSTVAC with or without GM-CSF who remain event-free (radiological progression, pain progression, initiation of chemotherapy, or death) at 6 months compared to placebo.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF
||Biological: PROSTVAC-V Biological: PROSTVAC-F Drug: GM-CSF|
Experimental: PROSTVAC-V/F-TRICOM + GM-CSF placebo
||Biological: PROSTVAC-V Biological: PROSTVAC-F Other: GM-CSF Placebo|
Placebo Comparator: Placebo Control
PROSTVAC V/F Placebo + GM-CSF Placebo
Other: GM-CSF Placebo
PROSTVAC V/F Placebo
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
|Contact: Paul Collinsemail@example.com|
|Contact: Janet Hurtfirstname.lastname@example.org|
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|Principal Investigator:||James L. Gulley, MD||National Cancer Institute (NCI)|
|Principal Investigator:||Philip Kantoff, MD||Dana-Farber Cancer Institute|