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

Last updated: September 2, 2010
Sponsor: Dendreon
Overall Status: Completed

Phase

3

Condition

Prostate Cancer

Urologic Cancer

Prostate Disorders

Treatment

N/A

Clinical Study ID

NCT00065442
D9902B
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

To qualify for this trial, you must have ALL of the following:

  • Histologically documented adenocarcinoma of the prostate

  • Cancer that has progressed while on adequate hormone therapy. This state of the disease is androgen independent prostate cancer (AIPC).

  • Cancer that has spread outside the prostate (metastatic) to lymph nodes or bone. Please note that if your cancer has spread to organs (e.g., liver, lung, brain), you are not eligible for the study.

  • The absence of or minimal current cancer-related pain

Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.

Study personnel will explain the trial in detail and answer any questions you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, study personnel will explain the reasons.

Study Design

Total Participants: 512
Study Start date:
July 01, 2003
Estimated Completion Date:
January 31, 2009

Study 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.

Connect with a study center

  • Can-Med Medical Research, Inc.

    Victoria, British Columbia V8T 5G1
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 4G5
    Canada

    Site Not Available

  • Urology CURC Scarborough

    Scarborough, Ontario M1S 4V5
    Canada

    Site Not Available

  • Princess Margaret Hospital

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Sunnybrook & Women's College HSC

    Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Hospital Notre Dame du CHUM

    Montreal, Quebec H2L 4M1
    Canada

    Site Not Available

  • South Orange County Urological

    Laguna Hills, California 92653
    United States

    Site Not Available

  • LLUMC for Molecular Biology and Gene Therapy

    Loma Linda, California 92354
    United States

    Site Not Available

  • UCLA

    Los Angeles, California 90095-1738
    United States

    Site Not Available

  • USC Keck School of Medicine

    Los Angeles, California 90089-9178
    United States

    Site Not Available

  • Comprehensive Cancer Center

    Palm Springs, California 982262
    United States

    Site Not Available

  • Sutter Cancer Center

    Sacramento, California 95816
    United States

    Site Not Available

  • Kaiser Permanente Medical Group

    San Diego, California 92120
    United States

    Site Not Available

  • Sharp HealthCare

    San Diego, California 92123
    United States

    Site Not Available

  • UCSF Cancer Center

    San Francisco, California 94115
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Denver, Colorado 80220
    United States

    Site Not Available

  • Connecticut Urological Research at Grove Hill

    New Britain, Connecticut 06052
    United States

    Site Not Available

  • Helen F. Graham Cancer Center

    Newark, Delaware 19713
    United States

    Site Not Available

  • Lombardi Cancer Center

    Washington, District of Columbia 20057
    United States

    Site Not Available

  • Walter Reid Army Medical Center

    Washington, District of Columbia 20307
    United States

    Site Not Available

  • Miami Cancer Center

    Miami, Florida 33133
    United States

    Site Not Available

  • Urology Center of South Florida

    Miami, Florida 33173
    United States

    Site Not Available

  • Cancer Centers of Florida

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Hematology/Oncology Associates of the Treasure Coast

    Port St. Lucie, Florida 34952
    United States

    Site Not Available

  • Georgia Urology, P.A.

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Midwest Prostate & Urology Health Center

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Loyola University

    Maywood, Illinois 60153
    United States

    Site Not Available

  • Lutheran General Cancer Center

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Chesapeake Urology Associates

    Baltimore, Maryland 21204
    United States

    Site Not Available

  • Myron I Murdock MD LLC

    Greenbelt, Maryland 20770
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02115-6084
    United States

    Site Not Available

  • Lahey Clinic (Department of Urology)

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Nevada Cancer Institute

    Las Vegas, Nevada 89135
    United States

    Site Not Available

  • Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Associates in Urology, LLC

    West Orange, New Jersey 07052
    United States

    Site Not Available

  • Albany Regional Cancer Center

    Albany, New York 12208
    United States

    Site Not Available

  • The Urological Institute of Northeastern New York

    Albany, New York 12208
    United States

    Site Not Available

  • North Shore Hematology Oncology Associates

    East Setauket, New York 11733
    United States

    Site Not Available

  • New York Medical College

    Hawthorne, New York 10532
    United States

    Site Not Available

  • Beth Israel Cancer Center

    New York, New York 10003
    United States

    Site Not Available

  • Clinical Cancer Center

    New York, New York 10029
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York 10029
    United States

    Site Not Available

  • New York University

    New York, New York 10016
    United States

    Site Not Available

  • Staten Island Urological Research

    Staten Island, New York 10304
    United States

    Site Not Available

  • McKay Urology

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27705
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267-0502
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • EACRI

    Portland, Oregon 97213
    United States

    Site Not Available

  • Kaiser Permanente Medical Group

    Portland, Oregon 97227-1191
    United States

    Site Not Available

  • Oregon Urology Specialists

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Center for Urologic Care

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

  • Jefferson Medical College

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Grand Strand Urology

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

  • Mary Crowley

    Dallas, Texas 75246
    United States

    Site Not Available

  • Urology Associates of North Texas

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Urology of Virginia, PC

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Seattle Cancer Care Alliance

    Seattle, Washington 98109
    United States

    Site Not Available

  • Virginia Mason Medical Center

    Seattle, Washington 98101
    United States

    Site Not Available

  • Cancer Care Northwest

    Spokane, Washington 99218
    United States

    Site Not Available

  • Wenatchee Valley Medical Center

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin, Madison

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • St. Luke's Hospital Immunotherapy Program

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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