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Prostate CancerPhase 2NCT00078585

PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

A Phase 2 study testing PROSTVAC®-VF/TRICOM™ in people with Prostate Cancer, run by Bavarian Nordic at 47 sites in United States.

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

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. 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?
PROSTVAC®-VF/TRICOM™
How many people
120 participants
Where
47 sitesUnited States
Study dates
Nov 2003to Jan 2009
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Male patients > 18 years of age who have been vaccinated against smallpox;
  • Histological confirmation of adenocarcinoma of the prostate with evidence of metastatic disease including either of the following: Lymph node metastasis measurable by CT and/or Bone metastasis evaluable by bone scan;
  • Despite hormone therapy, there is evidence of two consecutive increases in PSA (Prostate Specific Antigen);
  • Gleason Score of 7 or lower at initial diagnosis.

Please note that there are additional eligibility criteria that you must meet to qualify.

If you do qualify to participate, study personnel will explain the trial in detail and answer any questions you may have. 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

47 sites in 1 country.

47 sites in 1 country

United States47 sites

  • The Urological Institute of Northeastern New York

    Albany, New York, 12208

  • Urology Group of New Mexico

    Albuquerque, New Mexico, 87109

  • Alaska Clinical Research Center

    Anchorage, Alaska, 99508

  • Arlington Cancer Center

    Arlington, Texas, 76012

  • Midtown Urology

    Atlanta, Georgia, 30308

  • UCHSC Anschutz Cancer Pavilion

    Aurora, Colorado, 80010

  • South Florida Medical Research

    Aventura, Florida, 33180

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Wyoming Research Foundation, Inc.

    Cheyenne, Wyoming, 82001

  • Prairie Medical Associates, Ltd.

    Chicago, Illinois, 60616

  • North Idaho Urology

    Coeur d'Alene, Idaho, 83814

  • Urology Clinic of North Texas, PA

    Dallas, Texas, 75231

  • Urologic Associates, PC

    Davenport, Iowa, 52807

  • Texas Cancer Center

    Fort Worth, Texas, 76104

  • Urology Associates of Central California

    Fresno, California, 93720

  • Medical and Surgical Specialists

    Galesburg, Illinois, 61401

  • AccuMed Research Associates

    Garden City, New York, 11530

  • The Urology Center

    Greensboro, North Carolina, 27403

  • Urology Centers of Alabama

    Homewood, Alabama, 35209

  • Metropolitan Urology

    Jeffersonville, Indiana, 47130

  • San Diego Urology Center

    La Mesa, California, 91942

  • Lawrenceville Urology

    Lawrenceville, New Jersey, 08648

  • Loma Linda University

    Loma Linda, California, 92354

  • Atlantic Urology Medical Group

    Long Beach, California, 90806

  • Midwest Research Specialists, LLC

    Milwaukee, Wisconsin, 53209

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Urology Associates Clinical Research

    Nashville, Tennessee, 37209

  • The Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • Advanced Research Institute

    New Port Richey, Florida, 34652

  • Columbia Presbyterian Medical Center

    New York, New York, 10032

  • Nyack Hospital

    Nyack, New York, 10960

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • Virginia Urology Center

    Richmond, Virginia, 23235

  • McGuire Research Institute

    Richmond, Virginia, 23249

  • Salt Lake Research

    Salt Lake City, Utah, 84124

  • Pacific Clinical Research

    Santa Monica, California, 90404

  • University of Vermont

    South Burlington, Vermont, 05403

  • Western Clinical Research, Inc.

    Torrance, California, 90505

  • Carle Clinic Cancer Center

    Urbana, Illinois, 61801

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Connecticut Clinical Research Center

    Waterbury, Connecticut, 06708

  • Texas Cancer Care

    Weatherford, Texas, 76086

Other trials in United States

About this study

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

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.

Conditions
Prostate Cancer
Being tested
PROSTVAC®-VF/TRICOM™
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • PROSTVAC®-VF/TRICOM™Biological

Timeline

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

  1. First posted3 Mar 2004 (estimated)
  2. Study startNov 2003
  3. Primary completion4 Jan 2006
  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 2
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
120 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00078585
Sponsor's protocol ID
TBC-PRO-002
Status last verified
Sep 2017
First submitted
1 Mar 2004
Last updated
11 Sep 2017
Results posted
No

Publications

  • Kantoff PW, Schuetz TJ, Blumenstein BA, Glode LM, Bilhartz DL, Wyand M, Manson K, Panicali DL, Laus R, Schlom J, Dahut WL, Arlen PM, Gulley JL, Godfrey WR. Overall survival analysis of a phase II randomized controlled trial of a Poxviral-based PSA-targeted immunotherapy in metastatic castration-resistant prostate cancer. J Clin Oncol. 2010 Mar 1;28(7):1099-105. doi: 10.1200/JCO.2009.25.0597. Epub 2010 Jan 25.

    PubMed 20100959

  • Kantoff PW, Gulley JL, Pico-Navarro C. Revised Overall Survival Analysis of a Phase II, Randomized, Double-Blind, Controlled Study of PROSTVAC in Men With Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2017 Jan;35(1):124-125. doi: 10.1200/JCO.2016.69.7748. Epub 2016 Sep 30. No abstract available.

    PubMed 27646950

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PROSTVAC®-VF/TRICOM™ in people with Prostate Cancer, run by Bavarian Nordic at 47 sites in United States.

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 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00078585, which also lists 2 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 11 Sep 2017.

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