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Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

This study is ongoing, but not recruiting participants.

Sponsored by: Dendreon
Information provided by: Dendreon
ClinicalTrials.gov Identifier: NCT00065442
  Purpose

Provenge is an investigational product designed to activate a man's own antigen presenting cells, a type of immune cell, so that they can detect prostate cancer cells and initiate an immune response against them.

Having completed Phase 1 and Phase 2 clinical trials, Provenge is now at the Phase 3 level. One important Phase 3 trial of Provenge has been completed; the current trial is also a Phase 3 study.

If you decide to participate and are eligible, you will be enrolled in the study and randomly assigned to receive either active product or placebo. There are two chances in three that you will receive Provenge. After receiving treatment, you will be monitored at regular intervals until the study endpoints are met. At the end of the trial, men who received placebo will have the opportunity to be treated with active product in another study.


Condition Intervention Phase
Prostate Cancer
Biological: Provenge
Phase III

MedlinePlus related topics:   Cancer    Prostate Cancer   

ChemIDplus related topics:   Sipuleucel-T    Provenge    Gonadorelin    Gonadorelin hydrochloride    LH-RH   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   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

Further study details as provided by Dendreon:

Estimated Enrollment:   500
Study Start Date:   July 2003

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065442

Show 73 study locations  Show 73 Study Locations

Sponsors and Collaborators
Dendreon

Investigators
Study Chair:     Paul Schellhammer, MD     Devine Tidewater Urology    
  More Information

Prostate Cancer Research Institute  This link exits the ClinicalTrials.gov site
 
National Prostate Cancer Coalition  This link exits the ClinicalTrials.gov site
 
USTOO International  This link exits the ClinicalTrials.gov site
 
American Foundation of Urological Diseases  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   D9902B
First Received:   July 23, 2003
Last Updated:   July 11, 2008
ClinicalTrials.gov Identifier:   NCT00065442
Health Authority:   United States: Food and Drug Administration

Keywords provided by Dendreon:
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

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on September 05, 2008




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