Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
This study has been completed.
Sponsor:
Dendreon
Information provided by:
Dendreon
ClinicalTrials.gov Identifier:
NCT00065442
First received: July 23, 2003
Last updated: September 2, 2010
Last verified: September 2010
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065442
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| 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 May 21, 2013