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

This study has been completed.
Sponsor:
Information provided by:
Dendreon
ClinicalTrials.gov Identifier:
NCT00065442
First received: July 23, 2003
Last updated: September 2, 2010
Last verified: September 2010
  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: Sipuleucel-T
Biological: APC-Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Dendreon:

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


Secondary Outcome Measures:
  • Time to Objective Disease Progression [ Time Frame: Analysis conducted at the time of overall survival analysis ] [ Designated as safety issue: Yes ]
    Measured by imaging studies; confirmed by independent imaging review


Enrollment: 512
Study Start Date: July 2003
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
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, see Learn About Clinical Studies.

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

  Show 71 Study Locations
Sponsors and Collaborators
Dendreon
Investigators
Study Chair: Paul Schellhammer, MD Devine Tidewater Urology
  More Information

Additional Information:
No publications provided by Dendreon

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Liz Smith, Dendreon Corporation
ClinicalTrials.gov Identifier: NCT00065442     History of Changes
Obsolete Identifiers: NCT00084760
Other Study ID Numbers: D9902B
Study First Received: July 23, 2003
Results First Received: May 28, 2010
Last Updated: September 2, 2010
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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Androgens
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014