Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Public ClinicalTrials.gov record NCT00065442. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00065442
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 512 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 2003 (Type not available)
- Primary completion
- Jan 2009 (Actual)
- Completion
- Jan 2009 (Actual)
- Last update posted
- Sep 6, 2010
2003 – 2009
United States locations
- U.S. sites
- 65
- U.S. states
- 25
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| 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 | — |
| UCLA | Los Angeles | California | 90095-1738 | — |
| Comprehensive Cancer Center | Palm Springs | California | 982262 | — |
| Sutter Cancer Center | Sacramento | California | 95816 | — |
| Kaiser Permanente Medical Group | San Diego | California | 92120 | — |
| Sharp HealthCare | San Diego | California | 92123 | — |
| UCSF Cancer Center | San Francisco | California | 94115 | — |
| Rocky Mountain Cancer Center | Denver | Colorado | 80220 | — |
| Connecticut Urological Research at Grove Hill | New Britain | Connecticut | 06052 | — |
| Helen F. Graham Cancer Center | Newark | Delaware | 19713 | — |
| Lombardi Cancer Center | Washington D.C. | District of Columbia | 20057 | — |
| Walter Reid Army Medical Center | Washington D.C. | District of Columbia | 20307 | — |
| Miami Cancer Center | Miami | Florida | 33133 | — |
| Urology Center of South Florida | Miami | Florida | 33173 | — |
| Cancer Centers of Florida | Ocoee | Florida | 34761 | — |
| Hematology/Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | — |
| Georgia Urology, P.A. | Atlanta | Georgia | 30342 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Midwest Prostate & Urology Health Center | Chicago | Illinois | 60640 | — |
| Loyola University | Maywood | Illinois | 60153 | — |
| Lutheran General Cancer Center | Park Ridge | Illinois | 60068 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Chesapeake Urology Associates | Baltimore | Maryland | 21204 | — |
| Myron I Murdock MD LLC | Greenbelt | Maryland | 20770 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115-6084 | — |
| Lahey Clinic (Department of Urology) | Burlington | Massachusetts | 01805 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Associates in Urology, LLC | West Orange | New Jersey | 07052 | — |
| Albany Regional Cancer Center | Albany | New York | 12208 | — |
| The Urological Institute of Northeastern New York | Albany | New York | 12208 | — |
| North Shore Hematology Oncology Associates | East Setauket | New York | 11733 | — |
| New York Medical College | Hawthorne | New York | 10532 | — |
| 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 | — |
| Staten Island Urological Research | Staten Island | New York | 10304 | — |
| McKay Urology | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267-0502 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| EACRI | Portland | Oregon | 97213 | — |
| Kaiser Permanente Medical Group | Portland | Oregon | 97227-1191 | — |
| Oregon Urology Specialists | Springfield | Oregon | 97477 | — |
| Center for Urologic Care | Bryn Mawr | Pennsylvania | 19010 | — |
| Jefferson Medical College | Philadelphia | Pennsylvania | 19107 | — |
| Grand Strand Urology | Myrtle Beach | South Carolina | 29572 | — |
| Mary Crowley | Dallas | Texas | 75246 | — |
| Urology Associates of North Texas | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Urology of Virginia, PC | Norfolk | Virginia | 23502 | — |
| Urology of Virginia, PC | Norfolk | Virginia | 23507 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| Cancer Care Northwest | Spokane | Washington | 99218 | — |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801 | — |
| University of Wisconsin, Madison | Madison | Wisconsin | 53792 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
| St. Luke's Hospital Immunotherapy Program | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00065442, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 6, 2010 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00065442 live on ClinicalTrials.gov.