ClinicalTrials.gg
TerminatedNCT00089856Updated Nov 5, 2008

GVAX® Vaccine for Prostate Cancer vs Docetaxel & Prednisone in Patients With Metastatic Hormone-Refractory Prostate Cancer

A Phase 3 interventional study of Immunotherapy with allogeneic prostate vaccine and Chemotherapy (Taxotere and prednisone) in Prostate Cancer, sponsored by Cell Genesys. Terminated at 126 sites in 8 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-11-05.

Sponsored by Cell Genesys · Phase 3, Interventional, and Treatment

Why this study was terminated
Based on futility analysis showing \<30% chance of meeting primary endpoint.
Phase
Phase 3
Study type
Interventional
Enrollment
626
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

The purpose of this study is to compare the duration of survival between GVAX® immunotherapy for prostate cancer and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past.

02

Conditions studied

  • Prostate Cancer

Keywords

  • Prostate
  • Cancer
  • Metastatic
  • Hormone-refractory
  • GVAX
  • Chemotherapy
  • Taxotere
  • Docetaxel
  • Prednisone
  • Vaccine
  • Allogeneic cells
  • Advanced Prostate Cancer
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 626 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Cell Genesys is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate
  • Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy
  • Detectable metastases
  • Any Gleason score
  • ECOG performance status 0-2

Exclusion criteria

Exclusion Criteria:

  • Prior treatment with chemotherapy
  • Prior Immunotherapy
  • Prior treatment with gene therapy
  • Significant cancer related pain
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
626 participants (actual)

Study arms

  • Other
    2

    Standard of care - chemotherapy

    Drug: Chemotherapy (Taxotere and prednisone)

  • Experimental
    1

    Immunotherapy

    Biological: Immunotherapy with allogeneic prostate vaccine

Interventions

  • BiologicalImmunotherapy with allogeneic prostate vaccine

    Immunotherapy with allogeneic prostate vaccine

  • DrugChemotherapy (Taxotere and prednisone)

    Chemotherapy (Taxotere and prednisone)

06

What researchers measure

Primary outcomes

  1. Survival

    Time frame: 0

Secondary outcomes

  1. Bone pain and bone related events

    Time frame: 0

07

Study locations

126 sites
  • Central Alabama Oncology, LLC
    Alabaster, Alabama 35007, United States
  • Alaska Clinical Research Center
    Anchorage, Alaska 99508, United States
  • Palo Verde Hematology/Oncology
    Glendale, Arizona 85304, United States
  • Mayo Clinic Scottsdale
    Scottsdale, Arizona 85259, United States
  • ACRC/Arizona Clinical Res. Ctr. Inc.
    Tuscon, Arizona 85715, United States
  • Arkansas Cancer Research Center
    Little Rock, Arkansas 72205, United States
  • Compassionate Cancer Care Medical Group, Inc.
    Corona, California 92882, United States
  • Pacific Coast Hem Onc. Medical Group
    Fountain Valley, California 92708, United States
  • California Cancer Care
    Greenbrae, California 94904, United States
  • Center for Urological Research
    La Mesa, California 91942, United States
  • Oncology Care Medical Associates
    Montebello, California 90640, United States
  • UC Irvine Medical Center
    Orange, California 92868, United States
  • San Bernardino Urological Associates
    San Bernardino, California 92404, United States
  • Sharp Healthcare
    San Diego, California 92123, United States
  • California Pacific Medical Center
    San Francisco, California 94115, United States
  • Cancer Research & Prevention Center
    Soquel, California 95073, United States
  • San Diego Cancer Center
    Vista, California 92081, United States
  • Univ. of Colorado Health Science Center
    Aurora, Colorado 80045, United States
  • Cancer Center of Colorado Springs
    Colorado Springs, Colorado 80907, United States
  • The Hope Clinic
    Bristol, Connecticut 06010, United States
  • Urology Center of Grove Hill
    New Britain, Connecticut 06052-1395, United States
  • Carl & Dorothy Bennett Cancer Center
    Stamford, Connecticut 06902, United States
  • Boca Raton Community Hospital, Inc.
    Boca Raton, Florida 33486, United States
  • Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
  • Integrated Community Oncology Network
    Jacksonville, Florida 32256, United States
  • Oncology-Hematology Group of South Florida/Advanced Medical Specialists
    Miami, Florida 33176, United States
  • Cancer Centers of Florida
    Ocoee, Florida 34761, United States
  • Hematology Oncology Associates of the Treasure Coast
    Port Saint Lucie, Florida 34952, United States
  • Urology Consultants
    Safety Harbor, Florida 34695, United States
  • Atlanta VAMC
    Atlanta, Georgia 30033, United States
  • Georgia Cancer Specialists
    Atlanta, Georgia 30084, United States
  • Peachtree Hematology Oncology Consultants, PC
    Atlanta, Georgia 30309, United States
  • Winship Cancer Institute, Emory University
    Atlanta, Georgia 30322, United States
  • Central Georgia Cancer Care, P.C.
    Macon, Georgia 31201, United States
  • Straub Clinic & Hospital
    Honolulu, Hawaii 96813, United States
  • University of Illinois at Chicago
    Chicago, Illinois 60612, United States
  • Welborn Clinic Research Center
    Evansville, Indiana 47713, United States
  • Fort Wayne Medical Oncology/Hematology Inc.
    Fort Wayne, Indiana 46815, United States
  • Louisiana Oncology Associates
    Lafayette, Louisiana 70506, United States
  • Johns Hopkins University
    Baltimore, Maryland 21231, United States
  • Frederick Memorial Hospital Regional Cancer Therapy Center
    Frederick, Maryland 21701, United States
  • West Michigan Regional Cancer and Blood Center
    Free Soil, Michigan 49411, United States
  • William Beaumont Hospital, Cancer Clinical Trials Office
    Royal Oak, Michigan 48073-6706, United States
  • Newland Medical Associates, P.C.
    Southfield, Michigan 48075, United States
  • Hematology Oncology Consultants, Inc.
    St Louis, Missouri 63136, United States
  • Deaconess Billings Clinic
    Billings, Montana 59101, United States
  • Hematology/Oncology Centers of the Northern Rockies, P.C.
    Billings, Montana 59101, United States
  • Omaha VA Medical Center
    Omaha, Nebraska 68105, United States
  • Omaha VA Medical Center
    Omaha, Nebraska 68198-7680, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • The Center for Cancer & Hematologic Disease
    Cherry Hill, New Jersey 08003, United States
  • Hematology-Oncology Associates of Northern New Jersey
    Morristown, New Jersey 07962, United States
  • Summit Medical Group/Overlook Oncology Center
    Summit, New Jersey 07901, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
  • SUNY Upstate Medical University
    Syracuse, New York 13210, United States
  • Jacobi Medical Center
    The Bronx, New York 10461, United States
  • Presbyterian Hospital/ Center for Cancer Research
    Charlotte, North Carolina 28204, United States
  • Northwestern Carolina Hematology Oncology, PA
    Hickory, North Carolina 28602, United States
  • Medcenter One Cancer Care / Odyssey Research
    Bismarck, North Dakota 58501, United States
  • Dakota Cancer Institute
    Fargo, North Dakota 58103, United States
  • Gabrail Cancer Center
    Canton, Ohio 44718, United States
  • Cleveland Clinic Foundation, Taussig Cancer Center
    Cleveland, Ohio 44195, United States
  • University of Oklahoma
    Oklahoma City, Oklahoma 73104, United States
  • Providence Portland Medical Center
    Portland, Oregon 97213, United States
  • Urologic Surgery PC
    Bala-Cynwyd, Pennsylvania 19004, United States
  • Medical Oncology Associates
    Kingston, Pennsylvania 18704, United States
  • Lancaster Cancer Center, Ltd
    Lancaster, Pennsylvania 17601, United States
  • Urological Associates of Lancaster
    Lancaster, Pennsylvania 17604, United States
  • University of Pittsburgh Cancer Center
    Pittsburgh, Pennsylvania 15232, United States
  • Charleston Hematology Oncology
    Charleston, South Carolina 29403, United States
  • Memorial Health Care System
    Chattanooga, Tennessee 37404, United States
  • The West Clinic
    Memphis, Tennessee 38120, United States
  • The Don and Sybil Harrington Cancer Center
    Amarillo, Texas 79106, United States
  • Mary Crowley Medical Research Center
    Dallas, Texas 75201, United States
  • Center for Oncology Research and Treatment PA
    Dallas, Texas 75230, United States
  • Urology Specialists and Associates, P.A.
    Dallas, Texas 75231, United States
  • Mobley Research Center
    Houston, Texas 77024, United States
  • Urology San Antonio
    San Antonio, Texas 78229, United States
  • Tyler Cancer Center
    Tyler, Texas 75702, United States
  • Southwestern Oncology Research Department
    Bennington, Vermont 05201, United States
  • Virginia Oncology Associates
    Norfolk, Virginia 23502, United States
  • Virginia Mason Medical Center Urology
    Seattle, Washington 98101, United States
  • Seattle Cancer Care Alliance
    Seattle, Washington 98109, United States
  • ZNA Middelheim
    Antwerp, B-2020, Belgium
  • Imelda Ziekenhuis
    Bonheiden, 2820, Belgium
  • University Hospital Antwerp (UZA)
    Edegem, 2650, Belgium
  • UZ Gent
    Ghent, 9000, Belgium
  • Unversity Hospial Gent
    Ghent, B-9000, Belgium
  • Virga Jesse Ziekenhuis
    Hasselt, B-3500, Belgium
  • AZ Groeninge
    Kortrijk, B-8500, Belgium
  • Heilig Hartziekenhuis Roeselare Men
    Roeselare, B-8800, Belgium
  • Regionaal Ziekenhuis Sint Trudo
    Sint-Truiden, B-3800, Belgium
  • Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
  • CHUM Notre-Dam
    Montreal, Quebec H2L 4M1, Canada
  • McGill University
    Montreal, Quebec H2W1S6, Canada
  • Ultra Med Inc.
    Pointe-Claire, Quebec H9R 4S3, Canada
  • Centre Hopitalier Universitaire de Sherbrooke
    Sherbrooke, Quebec J1H 5N4, Canada
  • Centre Paul Papin
    Angers, 49033, France
  • Centre Francois Baclesse
    Caen, 14076, France
  • Centre Georges Francois Leclerc
    Dijon, 77980, France

Showing the first 100 of 126 sites across 8 countries.

08

References and documents

Publications

  • Vuky J, Corman JM, Porter C, Olgac S, Auerbach E, Dahl K. Phase II trial of neoadjuvant docetaxel and CG1940/CG8711 followed by radical prostatectomy in patients with high-risk clinically localized prostate cancer. Oncologist. 2013 Jun;18(6):687-8. doi: 10.1634/theoncologist.2011-0234. Epub 2013 Jun 5. PubMed 23740935 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2004, a primary completion of Oct 2008 and a completion of Oct 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2004
First posted
Aug 18, 2004
Start
Jul 2004
Primary completionActual
Oct 2008
CompletionActual
Oct 2008
Last update
Nov 5, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00089856
Lead sponsor
Cell Genesys
First posted
Aug 18, 2004
Start date
Jul 2004
Primary completion
Oct 2008
Completion
Oct 2008
Last update
Nov 5, 2008
View the source record on ClinicalTrials.gov ↗

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