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Spots Global Cancer Trial Database for Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

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We do not endorse or review these studies in any way.

Trial Identification

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

Conditions

Prostate Cancer

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

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

Contact Details

Name: Paul Schellhammer, MD

Affiliation: Devine Tidewater Urology

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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