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Brief Title: Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Official Title: A Randomized, Double Blind, Placebo Controlled Phase 3 Trial of Immunotherapy With Autologous Antigen Presenting Cells Loading With PA2024 (Provenge(R), APC8015) in Men With Metastatic Androgen Independent Prostatic Adenocarcinoma
Study ID: NCT00065442
Brief Summary: 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.
Detailed Description: The trial is being conducted at multiple study centers throughout the United States. The trial is a double-blind, placebo-controlled trial. Participants must meet specific eligibility criteria. Study personnel will determine your eligibility in a telephone interview and through routine medical tests (physical exam, blood tests, imaging scans) done at a study center. If you qualify for and decide to participate in the trial, you will have three product administrations over the course of one month.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
South Orange County Urological, Laguna Hills, California, United States
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, District of Columbia, United States
Walter Reid Army Medical Center, Washington, 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 St. 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
Myron I Murdock MD LLC, Greenbelt, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Lahey Clinic (Department of Urology), Burlington, Massachusetts, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Associates in Urology, LLC, West Orange, New Jersey, United States
Albany Regional Cancer Center, Albany, New York, United States
The Urological Institute of Northeastern New York, Albany, New York, United States
North Shore Hematology Oncology Associates, East Setauket, New York, United States
New York Medical College, Hawthorne, New York, United States
Beth Israel Cancer Center, New York, New York, United States
New York University, New York, New York, United States
Clinical Cancer Center, New York, New York, United States
Mount Sinai School of Medicine, New York, New York, United States
Staten Island Urological Research, Staten Island, New York, United States
McKay Urology, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
EACRI, Portland, Oregon, United States
Kaiser Permanente Medical Group, Portland, Oregon, United States
Oregon Urology Specialists, Springfield, Oregon, United States
Center for Urologic Care, Bryn Mawr, Pennsylvania, United States
Jefferson Medical College, Philadelphia, Pennsylvania, United States
Grand Strand Urology, Myrtle Beach, South Carolina, United States
Mary Crowley, Dallas, Texas, United States
Urology Associates of North Texas, Fort Worth, Texas, United States
Baylor College of Medicine, Houston, Texas, United States
University of Utah, Salt Lake City, Utah, United States
Urology of Virginia, PC, Norfolk, Virginia, United States
Urology of Virginia, PC, Norfolk, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Cancer Care Northwest, Spokane, Washington, United States
Wenatchee Valley Medical Center, Wenatchee, Washington, United States
University of Wisconsin, Madison, Madison, Wisconsin, United States
University of Wisconsin, Madison, Wisconsin, United States
St. Luke's Hospital Immunotherapy Program, Milwaukee, Wisconsin, United States
Can-Med Medical Research, Inc., Victoria, British Columbia, Canada
London Health Sciences Centre, London, Ontario, Canada
Urology CURC Scarborough, Scarborough, Ontario, Canada
Sunnybrook & Women's College HSC, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Hospital Notre Dame du CHUM, Montreal, Quebec, Canada
Name: Paul Schellhammer, MD
Affiliation: Devine Tidewater Urology
Role: STUDY_CHAIR