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Prostate CancerPhase 3NCT00065442

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

A Phase 3 study testing Sipuleucel-T in people with Prostate Cancer, run by Dendreon at 71 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Sipuleucel-T
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
512 participants
Where
71 sitesin 2 countries
Study dates
Jul 2003to Jan 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

71 sites in 2 countries.

71 sites in 2 countries

United States65 sites

  • Albany Regional Cancer Center

    Albany, New York, 12208

  • The Urological Institute of Northeastern New York

    Albany, New York, 12208

  • Georgia Urology, P.A.

    Atlanta, Georgia, 30342

  • Chesapeake Urology Associates

    Baltimore, Maryland, 21204

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115-6084

  • Center for Urologic Care

    Bryn Mawr, Pennsylvania, 19010

  • Lahey Clinic (Department of Urology)

    Burlington, Massachusetts, 01805

  • McKay Urology

    Charlotte, North Carolina, 28204

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Midwest Prostate & Urology Health Center

    Chicago, Illinois, 60640

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0502

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Mary Crowley

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80220

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • North Shore Hematology Oncology Associates

    East Setauket, New York, 11733

  • Urology Associates of North Texas

    Fort Worth, Texas, 76104

  • Myron I Murdock MD LLC

    Greenbelt, Maryland, 20770

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • New York Medical College

    Hawthorne, New York, 10532

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • South Orange County Urological

    Laguna Hills, California, 92653

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • LLUMC for Molecular Biology and Gene Therapy

    Loma Linda, California, 92354

  • USC Keck School of Medicine

    Los Angeles, California, 90089-9178

  • UCLA

    Los Angeles, California, 90095-1738

  • University of Wisconsin, Madison

    Madison, Wisconsin, 53792

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Loyola University

    Maywood, Illinois, 60153

  • Miami Cancer Center

    Miami, Florida, 33133

  • Urology Center of South Florida

    Miami, Florida, 33173

  • St. Luke's Hospital Immunotherapy Program

    Milwaukee, Wisconsin, 53215

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Grand Strand Urology

    Myrtle Beach, South Carolina, 29572

  • Connecticut Urological Research at Grove Hill

    New Britain, Connecticut, 06052

  • Beth Israel Cancer Center

    New York, New York, 10003

  • New York University

    New York, New York, 10016

  • Clinical Cancer Center

    New York, New York, 10029

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • Urology of Virginia, PC

    Norfolk, Virginia, 23502

  • Urology of Virginia, PC

    Norfolk, Virginia, 23507

  • Cancer Centers of Florida

    Ocoee, Florida, 34761

  • Comprehensive Cancer Center

    Palm Springs, California, 982262

  • Lutheran General Cancer Center

    Park Ridge, Illinois, 60068

  • Jefferson Medical College

    Philadelphia, Pennsylvania, 19107

  • Hematology/Oncology Associates of the Treasure Coast

    Port Saint Lucie, Florida, 34952

  • EACRI

    Portland, Oregon, 97213

  • Kaiser Permanente Medical Group

    Portland, Oregon, 97227-1191

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of Utah

    Salt Lake City, Utah, 84132

  • Kaiser Permanente Medical Group

    San Diego, California, 92120

  • Sharp HealthCare

    San Diego, California, 92123

  • UCSF Cancer Center

    San Francisco, California, 94115

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Cancer Care Northwest

    Spokane, Washington, 99218

  • Oregon Urology Specialists

    Springfield, Oregon, 97477

  • Staten Island Urological Research

    Staten Island, New York, 10304

  • Lombardi Cancer Center

    Washington D.C., District of Columbia, 20057

  • Walter Reid Army Medical Center

    Washington D.C., District of Columbia, 20307

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • Associates in Urology, LLC

    West Orange, New Jersey, 07052

Other trials in United States

Canada6 sites

  • London Health Sciences Centre

    London, Ontario, N6A 4G5

  • Hospital Notre Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • Urology CURC Scarborough

    Scarborough Village, Ontario, M1S 4V5

  • Sunnybrook & Women's College HSC

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • Can-Med Medical Research, Inc.

    Victoria, British Columbia, V8T 5G1

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Sipuleucel-T, APC-Placebo
Keywords
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
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sipuleucel-TBiological

    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.

  • APC-PlaceboBiological

    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.

Study groups in NCT00065442
Study groupRoleWhat they receive
APC-PlaceboPlacebo comparatorNot described
Receives: Biological: APC-Placebo
Sipuleucel-TActive comparatorNot described
Receives: Biological: Sipuleucel-T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Time from randomization until death due to any cause.

    Measured: Event-driven timeframe. Final analysis at 331 events.

Secondary outcomes (1)

  1. Time to Objective Disease Progression

    Measured by imaging studies; confirmed by independent imaging review

    Measured: Analysis conducted at the time of overall survival analysis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2003 (estimated)
  2. Study startJul 2003
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00065442
Sponsor's protocol ID
D9902B
Status last verified
Sep 2010
First submitted
23 Jul 2003
Last updated
6 Sep 2010

Publications

  • Ju M, Fan J, Zou Y, Yu M, Jiang L, Wei Q, Bi J, Hu B, Guan Q, Song X, Dong M, Wang L, Yu L, Wang Y, Kang H, Xin W, Zhao L. Computational Recognition of a Regulatory T-cell-specific Signature With Potential Implications in Prognosis, Immunotherapy, and Therapeutic Resistance of Prostate Cancer. Front Immunol. 2022 Jun 23;13:807840. doi: 10.3389/fimmu.2022.807840. eCollection 2022.

    PubMed 35812443

  • Small EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T. Prostate Cancer Prostatic Dis. 2014 Sep;17(3):259-64. doi: 10.1038/pcan.2014.21. Epub 2014 Jun 24.

    PubMed 24957547

  • Flanigan RC, Polcari AJ, Shore ND, Price TH, Sims RB, Maher JC, Whitmore JB, Corman JM. An analysis of leukapheresis and central venous catheter use in the randomized, placebo controlled, phase 3 IMPACT trial of Sipuleucel-T for metastatic castrate resistant prostate cancer. J Urol. 2013 Feb;189(2):521-6. doi: 10.1016/j.juro.2012.09.029. Epub 2012 Dec 14.

    PubMed 23253957

  • Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. doi: 10.1056/NEJMoa1001294.

    PubMed 20818862

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sipuleucel-T in people with Prostate Cancer, run by Dendreon at 71 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Event-driven timeframe. Final analysis at 331 events.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00065442, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2010.

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