At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,297 enrolled
Drug / intervention
PROSTVAC-V +4 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating PROSTVAC-V, PROSTVAC-F, and 3 other interventions for Prostate Cancer Metastatic. Completed, enrolled 1,297 participants across 220 sites in 16 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer Metastatic
CountriesAustralia, Belgium, Canada, Denmark, Estonia, France, Germany, Iceland, Israel, Netherlands, Poland, Puerto Rico, Russia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartNov 2011
Primary CompletionSep 2017
Study CompletionDec 2017
TodayJul 2026
First PostedMar 24, 2011
Enrollment StartNov 28, 2011
Primary CompletionSep 25, 2017
Study CompletionDec 15, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.3 years ago
Interventions
PROSTVAC-Vbiological
PROSTVAC-Fbiological
GM-CSFdrug
GM-CSF Placeboother
Placebobiological
PROSTVAC V/F Placebo