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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065442
• Other study ID #: D9902B
• Status: Completed
• Phase: Phase 3
• First received: July 23, 2003
• Last updated: September 2, 2010
• Start date: July 2003
• Est. completion date: January 2009

Study information

• Verified date: September 2010
• Source: Dendreon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00084760

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Hospital Notre Dame du CHUM	Montreal	Quebec
Canada	Urology CURC Scarborough	Scarborough	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Sunnybrook & Women's College HSC	Toronto	Ontario
Canada	Can-Med Medical Research, Inc.	Victoria	British Columbia
United States	Albany Regional Cancer Center	Albany	New York
United States	The Urological Institute of Northeastern New York	Albany	New York
United States	Georgia Urology, P.A.	Atlanta	Georgia
United States	Chesapeake Urology Associates	Baltimore	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Center for Urologic Care	Bryn Mawr	Pennsylvania
United States	Lahey Clinic (Department of Urology)	Burlington	Massachusetts
United States	McKay Urology	Charlotte	North Carolina
United States	Midwest Prostate & Urology Health Center	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Mary Crowley	Dallas	Texas
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Duke University Medical Center	Durham	North Carolina
United States	North Shore Hematology Oncology Associates	East Setauket	New York
United States	Urology Associates of North Texas	Fort Worth	Texas
United States	Myron I Murdock MD LLC	Greenbelt	Maryland
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	New York Medical College	Hawthorne	New York
United States	Baylor College of Medicine	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	South Orange County Urological	Laguna Hills	California
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	LLUMC for Molecular Biology and Gene Therapy	Loma Linda	California
United States	UCLA	Los Angeles	California
United States	USC Keck School of Medicine	Los Angeles	California
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Wisconsin, Madison	Madison	Wisconsin
United States	Loyola University	Maywood	Illinois
United States	Miami Cancer Center	Miami	Florida
United States	Urology Center of South Florida	Miami	Florida
United States	St. Luke's Hospital Immunotherapy Program	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Grand Strand Urology	Myrtle Beach	South Carolina
United States	Connecticut Urological Research at Grove Hill	New Britain	Connecticut
United States	Beth Israel Cancer Center	New York	New York
United States	Clinical Cancer Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	New York University	New York	New York
United States	Helen F. Graham Cancer Center	Newark	Delaware
United States	Urology of Virginia, PC	Norfolk	Virginia
United States	Urology of Virginia, PC	Norfolk	Virginia
United States	Cancer Centers of Florida	Ocoee	Florida
United States	Comprehensive Cancer Center	Palm Springs	California
United States	Lutheran General Cancer Center	Park Ridge	Illinois
United States	Jefferson Medical College	Philadelphia	Pennsylvania
United States	Hematology/Oncology Associates of the Treasure Coast	Port St. Lucie	Florida
United States	EACRI	Portland	Oregon
United States	Kaiser Permanente Medical Group	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Sutter Cancer Center	Sacramento	California
United States	University of Utah	Salt Lake City	Utah
United States	Kaiser Permanente Medical Group	San Diego	California
United States	Sharp HealthCare	San Diego	California
United States	UCSF Cancer Center	San Francisco	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Cancer Care Northwest	Spokane	Washington
United States	Oregon Urology Specialists	Springfield	Oregon
United States	Staten Island Urological Research	Staten Island	New York
United States	Lombardi Cancer Center	Washington	District of Columbia
United States	Walter Reid Army Medical Center	Washington	District of Columbia
United States	Wenatchee Valley Medical Center	Wenatchee	Washington
United States	Associates in Urology, LLC	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Dendreon

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Time from randomization until death due to any cause.	Event-driven timeframe. Final analysis at 331 events.	Yes
Secondary	Time to Objective Disease Progression	Measured by imaging studies; confirmed by independent imaging review	Analysis conducted at the time of overall survival analysis	Yes

External Links

•   Prostate Cancer Research Institute
•   USTOO International