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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00065442
Recruitment Status : Completed
First Posted : July 24, 2003
Results First Posted : September 6, 2010
Last Update Posted : September 6, 2010
Sponsor:
Information provided by:
Dendreon

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Biological: Sipuleucel-T Biological: APC-Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Study Start Date : July 2003
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: APC-Placebo Biological: APC-Placebo
Each dose of APC-Placebo contains approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
Active Comparator: Sipuleucel-T Biological: Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with a PAP-GM-CSF. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Event-driven timeframe. Final analysis at 331 events. ]
    Time from randomization until death due to any cause.


Secondary Outcome Measures :
  1. Time to Objective Disease Progression [ Time Frame: Analysis conducted at the time of overall survival analysis ]
    Measured by imaging studies; confirmed by independent imaging review


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065442


Locations
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Sponsors and Collaborators
Dendreon
Investigators
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Study Chair: Paul Schellhammer, MD Devine Tidewater Urology
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Liz Smith, Dendreon Corporation
ClinicalTrials.gov Identifier: NCT00065442    
Obsolete Identifiers: NCT00084760
Other Study ID Numbers: D9902B
First Posted: July 24, 2003    Key Record Dates
Results First Posted: September 6, 2010
Last Update Posted: September 6, 2010
Last Verified: September 2010
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
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases