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

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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

Primary Efficacy Objective: to ascertain whether the overall survival of subjects randomized to Arm V+G (PROSTVAC-V/F plus GM-CSF) or to Arm V (PROSTVAC-V/F) is superior to that from subjects randomized to Arm P (placebo control).
Secondary Efficacy Objective: to ascertain whether a greater proportion of subjects randomized to Arm V+G or Arm V remain event-free (radiological progression, pain progression, chemotherapy initiation, or death) at 6 months (or early termination) as compared to the subjects randomized to Arm P.
Safety Objective: to futher characterize the safety and tolerability of PROSTVAC immunotherapy.

Protocol Number081304
Principal InvestigatorMark Stein
PhasePhase III
ScopeNational
Applicable Disease SitesProstate
Therapies InvolvedChemotherapy (NOS)
Drugs InvolvedGM-CSF
PROSTVAC-VF
PLACEBO
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.