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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
Not Enrolling
Prostate Cancer

Thank you

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:


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:


Principal Investigator

Paul Schellhammer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Devine Tidewater Urology


United States: Food and Drug Administration

Study ID:




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



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