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
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||512 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Placebo Comparator: 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||
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.
- Overall Survival [ Time Frame: Event-driven timeframe. Final analysis at 331 events. ]Time from randomization until death due to any cause.
- 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
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
|Study Chair:||Paul Schellhammer, MD||Devine Tidewater Urology|