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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



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Georgia Urology, P.A.Atlanta, Georgia  30342
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Indiana UniversityIndianapolis, Indiana  46202
University of WisconsinMadison,, Wisconsin  53792-5666
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Connecticut Urological Research at Grove HillNew Britain, Connecticut  06052
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Miami Cancer CenterMiami, Florida  33133
Urology Center of South FloridaMiami, Florida  33173
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Midwest Prostate & Urology Health CenterChicago, Illinois  60640
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Chesapeake Urology AssociatesBaltimore, Maryland  21204
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