Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Completed · Phase 3 · Has a placebo group
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00065442
- Run by
- Dendreon
- People needed
- 512
- Starts
- 2003-07-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2010-09-06
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- LLUMC for Molecular Biology and Gene Therapy — Loma Linda, California, United States
- USC Keck School of Medicine — Los Angeles, California, United States
- UCLA — Los Angeles, California, United States
- Comprehensive Cancer Center — Palm Springs, California, United States
- Sutter Cancer Center — Sacramento, California, United States
- Kaiser Permanente Medical Group — San Diego, California, United States
- Sharp HealthCare — San Diego, California, United States
- UCSF Cancer Center — San Francisco, California, United States
- Rocky Mountain Cancer Center — Denver, Colorado, United States
- Connecticut Urological Research at Grove Hill — New Britain, Connecticut, United States
- Helen F. Graham Cancer Center — Newark, Delaware, United States
- Lombardi Cancer Center — Washington D.C., District of Columbia, United States
- Walter Reid Army Medical Center — Washington D.C., District of Columbia, United States
- Miami Cancer Center — Miami, Florida, United States
- Urology Center of South Florida — Miami, Florida, United States
- Cancer Centers of Florida — Ocoee, Florida, United States
- Hematology/Oncology Associates of the Treasure Coast — Port Saint Lucie, Florida, United States
- Georgia Urology, P.A. — Atlanta, Georgia, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Midwest Prostate & Urology Health Center — Chicago, Illinois, United States
- Loyola University — Maywood, Illinois, United States
- Lutheran General Cancer Center — Park Ridge, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- Chesapeake Urology Associates — Baltimore, Maryland, United States
- South Orange County Urological — Laguna Hills, California, United States
Full record on ClinicalTrials.gov
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