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

September 2, 2010 updated by: Dendreon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

512

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Event-driven timeframe. Final analysis at 331 events.
Time from randomization until death due to any cause.
Event-driven timeframe. Final analysis at 331 events.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Objective Disease Progression
Time Frame: Analysis conducted at the time of overall survival analysis
Measured by imaging studies; confirmed by independent imaging review
Analysis conducted at the time of overall survival analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dendreon

Investigators

  • Study Chair: Paul Schellhammer, MD, Devine Tidewater Urology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

July 23, 2003

First Submitted That Met QC Criteria

July 23, 2003

First Posted (Estimate)

July 24, 2003

Study Record Updates

Last Update Posted (Estimate)

September 6, 2010

Last Update Submitted That Met QC Criteria

September 2, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9902B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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