Provenge (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.

Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study.

If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.

Primary Outcome Measures:

• Overall Survival [ Time Frame: Event-driven timeframe. Final analysis at 331 events. ]
  • Time from randomization until death due to any cause.

Secondary Outcome Measures:

• Time to Objective Disease Progression [ Time Frame: Analysis conducted at the time of overall survival analysis ]
  • Measured by imaging studies; confirmed by independent imaging review