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

This study has been completed.
Sponsor:
Information provided by:
Dendreon
ClinicalTrials.gov Identifier:
NCT00065442
First received: July 23, 2003
Last updated: September 2, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Biological: Sipuleucel-T
Biological: APC-Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Event-driven timeframe. Final analysis at 331 events. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Measured by imaging studies; confirmed by independent imaging review


Enrollment: 512
Study Start Date: July 2003
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: APC-Placebo Biological: APC-Placebo
Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
Active Comparator: Sipuleucel-T Biological: Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065442

  Hide Study Locations
Locations
United States, California
South Orange County Urological
Laguna Hills, California, United States, 92653
LLUMC for Molecular Biology and Gene Therapy
Loma Linda, California, United States, 92354
USC Keck School of Medicine
Los Angeles, California, United States, 90089-9178
UCLA
Los Angeles, California, United States, 90095-1738
Comprehensive Cancer Center
Palm Springs, California, United States, 982262
Sutter Cancer Center
Sacramento, California, United States, 95816
Sharp HealthCare
San Diego, California, United States, 92123
Kaiser Permanente Medical Group
San Diego, California, United States, 92120
UCSF Cancer Center
San Francisco, California, United States, 94115
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80220
United States, Connecticut
Connecticut Urological Research at Grove Hill
New Britain, Connecticut, United States, 06052
United States, Delaware
Helen F. Graham Cancer Center
Newark, Delaware, United States, 19713
United States, District of Columbia
Walter Reid Army Medical Center
Washington, District of Columbia, United States, 20307
Lombardi Cancer Center
Washington, District of Columbia, United States, 20057
United States, Florida
Miami Cancer Center
Miami, Florida, United States, 33133
Urology Center of South Florida
Miami, Florida, United States, 33173
Cancer Centers of Florida
Ocoee, Florida, United States, 34761
Hematology/Oncology Associates of the Treasure Coast
Port St. Lucie, Florida, United States, 34952
United States, Georgia
Georgia Urology, P.A.
Atlanta, Georgia, United States, 30342
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Midwest Prostate & Urology Health Center
Chicago, Illinois, United States, 60640
Loyola University
Maywood, Illinois, United States, 60153
Lutheran General Cancer Center
Park Ridge, Illinois, United States, 60068
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Maryland
Chesapeake Urology Associates
Baltimore, Maryland, United States, 21204
Myron I Murdock MD LLC
Greenbelt, Maryland, United States, 20770
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
Lahey Clinic (Department of Urology)
Burlington, Massachusetts, United States, 01805
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Associates in Urology, LLC
West Orange, New Jersey, United States, 07052
United States, New York
Albany Regional Cancer Center
Albany, New York, United States, 12208
The Urological Institute of Northeastern New York
Albany, New York, United States, 12208
North Shore Hematology Oncology Associates
East Setauket, New York, United States, 11733
New York Medical College
Hawthorne, New York, United States, 10532
Clinical Cancer Center
New York, New York, United States, 10029
New York University
New York, New York, United States, 10016
Beth Israel Cancer Center
New York, New York, United States, 10003
Mount Sinai School of Medicine
New York, New York, United States, 10029
Staten Island Urological Research
Staten Island, New York, United States, 10304
United States, North Carolina
McKay Urology
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0502
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Kaiser Permanente Medical Group
Portland, Oregon, United States, 97227-1191
EACRI
Portland, Oregon, United States, 97213
Oregon Urology Specialists
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Center for Urologic Care
Bryn Mawr, Pennsylvania, United States, 19010
Jefferson Medical College
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Grand Strand Urology
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Mary Crowley
Dallas, Texas, United States, 75246
Urology Associates of North Texas
Fort Worth, Texas, United States, 76104
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
Urology of Virginia, PC
Norfolk, Virginia, United States, 23507
Urology of Virginia, PC
Norfolk, Virginia, United States, 23502
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Cancer Care Northwest
Spokane, Washington, United States, 99218
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
University of Wisconsin, Madison
Madison, Wisconsin, United States, 53792
St. Luke's Hospital Immunotherapy Program
Milwaukee, Wisconsin, United States, 53215
Canada, British Columbia
Can-Med Medical Research, Inc.
Victoria, British Columbia, Canada, V8T 5G1
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Urology CURC Scarborough
Scarborough, Ontario, Canada, M1S 4V5
Sunnybrook & Women's College HSC
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hospital Notre Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
Dendreon
Investigators
Study Chair: Paul Schellhammer, MD Devine Tidewater Urology
  More Information

Additional Information:
No publications provided by Dendreon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Liz Smith, Dendreon Corporation
ClinicalTrials.gov Identifier: NCT00065442     History of Changes
Obsolete Identifiers: NCT00084760
Other Study ID Numbers: D9902B
Study First Received: July 23, 2003
Results First Received: May 28, 2010
Last Updated: September 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dendreon:
prostate cancer
prostate
AIPC
androgen-independent
androgen independent
hormone insensitive
hormone-insensitive
PSA
prostatic adenocarcinoma
hormone-refractory
hormone refractory
HRPC
LHRH
immune therapy
immunotherapy
vaccine
dendritic cells
antigen-presenting cells
antigen presenting cells
cancer vaccine
therapeutic vaccine
therapeutic cancer vaccine
recombinant
biological
biopharmaceutical
biotechnology
biotech

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014