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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
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
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.
Inclusion 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
Time from randomization until death due to any cause.
Outcome Time Frame:
Event-driven timeframe. Final analysis at 331 events.
Safety Issue:
Yes
Principal Investigator
Paul Schellhammer, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Devine Tidewater Urology
Authority:
United States: Food and Drug Administration
Study ID:
D9902B
NCT ID:
NCT00065442
Start Date:
July 2003
Completion Date:
January 2009
Related Keywords:
- Prostate Cancer
- 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
- Adenocarcinoma
- Prostatic Neoplasms
Name | Location |
|---|---|
| Baylor College of Medicine | Houston, Texas 77030 |
| Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
| Mayo Clinic | Rochester, Minnesota 55905 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| Lombardi Cancer Center | Washington, District of Columbia 20007 |
| New York Medical College | Valhalla, New York 10595 |
| Virginia Mason Medical Center | Seattle, Washington 98111 |
| Rush University Medical Center | Chicago, Illinois 60612-3824 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Sutter Cancer Center | Sacramento, California 95816 |
| Albany Regional Cancer Center | Albany, New York 12208 |
| Hackensack University Medical Center | Hackensack, New Jersey 07601 |
| Rocky Mountain Cancer Center | Denver, Colorado 80218 |
| Kaiser Permanente Medical Group | Los Angeles, California 90027 |
| Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
| Seattle Cancer Care Alliance | Seattle, Washington 98109 |
| Urology Associates of North Texas | Arlington, Texas 76015 |
| University of Minnesota | Minneapolis, Minnesota 55455 |
| University of Utah | Salt Lake City, Utah |
| Cancer Care Northwest | Spokane, Washington 99202 |
| Duke University Medical Center | Durham, North Carolina 27710 |
| Helen F. Graham Cancer Center | Newark, Delaware 19713 |
| Comprehensive Cancer Center | Glendale, California 91204 |
| Center for Urologic Care | West Reading, Pennsylvania 19611 |
| Associates in Urology, LLC | West Orange, New Jersey 07052 |
| Grand Strand Urology | Myrtle Beach, South Carolina 29572 |
| Cancer Centers of Florida | Orlando, Florida 32806 |
| Oregon Urology Specialists | Eugene, Oregon 97401 |
| Mckay Urology | Charlotte,, North Carolina 28204 |
| UCLA | Los Angeles, California 90095 |
| UCSF Cancer Center | San Francisco, California 94143 |
| Sharp Healthcare | San Diego, California 92121 |
| Georgia Urology, P.A. | Atlanta, Georgia 30342 |
| Beth Israel Cancer Center | New York, New York 10003 |
| New York University | New York, New York 10016 |
| Indiana University | Indianapolis, Indiana 46202 |
| University of Wisconsin | Madison,, Wisconsin 53792-5666 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| South Orange County Urological | Laguna Hills, California 92653 |
| LLUMC for Molecular Biology and Gene Therapy | Loma Linda, California 92354 |
| USC Keck School of Medicine | Los Angeles, California 90089-9178 |
| Connecticut Urological Research at Grove Hill | New Britain, Connecticut 06052 |
| Walter Reid Army Medical Center | Washington, District of Columbia 20307 |
| Miami Cancer Center | Miami, Florida 33133 |
| Urology Center of South Florida | Miami, Florida 33173 |
| Hematology/Oncology Associates of the Treasure Coast | Port St. Lucie, Florida 34952 |
| Midwest Prostate & Urology Health Center | Chicago, Illinois 60640 |
| Loyola University | Maywood, Illinois 60153 |
| Lutheran General Cancer Center | Park Ridge, Illinois 60068 |
| Chesapeake Urology Associates | Baltimore, Maryland 21204 |
| Myron I Murdock MD LLC | Greenbelt, Maryland 20770 |
| Lahey Clinic (Department of Urology) | Burlington, Massachusetts 01805 |
| The Urological Institute of Northeastern New York | Albany, New York 12208 |
| North Shore Hematology Oncology Associates | East Setauket, New York 11733 |
| Clinical Cancer Center | New York, New York 10029 |
| Staten Island Urological Research | Staten Island, New York 10304 |
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
| Kaiser Permanente Medical Group | Portland, Oregon 97227-1191 |
| EACRI | Portland, Oregon 97213 |
| Jefferson Medical College | Philadelphia, Pennsylvania 19107 |
| Mary Crowley | Dallas, Texas 75246 |
| Urology of Virginia, PC | Norfolk, Virginia 23507 |
| University of Wisconsin, Madison | Madison, Wisconsin 53792 |
| St. Luke's Hospital Immunotherapy Program | Milwaukee, Wisconsin 53215 |
