PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Public ClinicalTrials.gov record NCT00078585. 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 Phase II Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC®-VF/TRICOM™ in Combination With GM-CSF in Patients With Androgen-Independent Adenocarcinoma of the Prostate
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will help determine if this vaccine can help fight cancer. This multi-center, double-blind, randomized, empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer (AIPC). All patients will be required to sign an informed consent prior to the performance of any on-study procedures. Patients will be screened for eligibility within 14 days prior to vaccine administration. Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment. The ratio of active treatment to empty vector control (placebo) is 2:1.
Study identification
- NCT ID
- NCT00078585
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 120 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
- Oct 31, 2003
- Primary completion
- Jan 3, 2006
- Completion
- Dec 31, 2008
- Last update posted
- Sep 10, 2017
2003 – 2009
United States locations
- U.S. sites
- 47
- U.S. states
- 28
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Urology Centers of Alabama | Homewood | Alabama | 35209 | — |
| Alaska Clinical Research Center | Anchorage | Alaska | 99508 | — |
| Urology Associates of Central California | Fresno | California | 93720 | — |
| San Diego Urology Center | La Mesa | California | 91942 | — |
| Loma Linda University | Loma Linda | California | 92354 | — |
| Atlantic Urology Medical Group | Long Beach | California | 90806 | — |
| Pacific Clinical Research | Santa Monica | California | 90404 | — |
| Western Clinical Research, Inc. | Torrance | California | 90505 | — |
| UCHSC Anschutz Cancer Pavilion | Aurora | Colorado | 80010 | — |
| Connecticut Clinical Research Center | Waterbury | Connecticut | 06708 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| South Florida Medical Research | Aventura | Florida | 33180 | — |
| Advanced Research Institute | New Port Richey | Florida | 34652 | — |
| Midtown Urology | Atlanta | Georgia | 30308 | — |
| North Idaho Urology | Coeur d'Alene | Idaho | 83814 | — |
| Prairie Medical Associates, Ltd. | Chicago | Illinois | 60616 | — |
| Medical and Surgical Specialists | Galesburg | Illinois | 61401 | — |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | — |
| Carle Clinic Cancer Center | Urbana | Illinois | 61801 | — |
| Metropolitan Urology | Jeffersonville | Indiana | 47130 | — |
| Urologic Associates, PC | Davenport | Iowa | 52807 | — |
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | — |
| Lawrenceville Urology | Lawrenceville | New Jersey | 08648 | — |
| The Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Urology Group of New Mexico | Albuquerque | New Mexico | 87109 | — |
| The Urological Institute of Northeastern New York | Albany | New York | 12208 | — |
| AccuMed Research Associates | Garden City | New York | 11530 | — |
| Columbia Presbyterian Medical Center | New York | New York | 10032 | — |
| Nyack Hospital | Nyack | New York | 10960 | — |
| The Urology Center | Greensboro | North Carolina | 27403 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15232 | — |
| Charleston Cancer Center | Charleston | South Carolina | 29406 | — |
| Urology Associates Clinical Research | Nashville | Tennessee | 37209 | — |
| Arlington Cancer Center | Arlington | Texas | 76012 | — |
| Urology Clinic of North Texas, PA | Dallas | Texas | 75231 | — |
| Texas Cancer Center | Fort Worth | Texas | 76104 | — |
| Texas Cancer Care | Weatherford | Texas | 76086 | — |
| Salt Lake Research | Salt Lake City | Utah | 84124 | — |
| University of Vermont | South Burlington | Vermont | 05403 | — |
| Virginia Urology Center | Richmond | Virginia | 23235 | — |
| McGuire Research Institute | Richmond | Virginia | 23249 | — |
| Midwest Research Specialists, LLC | Milwaukee | Wisconsin | 53209 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Wyoming Research Foundation, Inc. | Cheyenne | Wyoming | 82001 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00078585, 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 10, 2017 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00078585 live on ClinicalTrials.gov.