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

• 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: Dendreon
• Information provided by: Dendreon

Study Description

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

• 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

Arms and Interventions

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

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

• 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

  Show 71 Study Locations

Sponsors and Collaborators

Dendreon

Investigators

• Study Chair: Paul Schellhammer, MD; Devine Tidewater Urology

More Information

Additional Information:

Prostate Cancer Research Institute  USTOO International 

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

Small EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T. Prostate Cancer Prostatic Dis. 2014 Sep;17(3):259-64. doi: 10.1038/pcan.2014.21. Epub 2014 Jun 24.

Flanigan RC, Polcari AJ, Shore ND, Price TH, Sims RB, Maher JC, Whitmore JB, Corman JM. An analysis of leukapheresis and central venous catheter use in the randomized, placebo controlled, phase 3 IMPACT trial of Sipuleucel-T for metastatic castrate resistant prostate cancer. J Urol. 2013 Feb;189(2):521-6. doi: 10.1016/j.juro.2012.09.029. Epub 2012 Dec 14.

Kantoff PW, Higano CS, Shore ND, Berger ER, Small EJ, Penson DF, Redfern CH, Ferrari AC, Dreicer R, Sims RB, Xu Y, Frohlich MW, Schellhammer PF; IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010 Jul 29;363(5):411-22. doi: 10.1056/NEJMoa1001294.

• Responsible Party: Liz Smith, Dendreon Corporation
• ClinicalTrials.gov Identifier: NCT00065442 History of Changes
• Obsolete Identifiers: NCT00084760
• Other Study ID Numbers: D9902B
• First Posted: July 24, 2003
• 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:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Hormones; Androgens; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists