Clinical trial NCT00065442: Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: 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
Lead sponsor: Dendreon
Sponsor class: INDUSTRY
First posted: 2003-07-24
Enrollment: 512
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Overall Survival
timeFrame: Event-driven timeframe. Final analysis at 331 events.
Secondary outcomes:
measure: Time to Objective Disease Progression
timeFrame: Analysis conducted at the time of overall survival analysis
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: South Orange County Urological
state: California
city: Loma Linda
country: United States
facility: LLUMC for Molecular Biology and Gene Therapy
state: California
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: Sutter Cancer Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Sharp HealthCare
state: California
city: San Francisco
country: United States
facility: UCSF Cancer Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: New Britain
country: United States
facility: Connecticut Urological Research at Grove Hill
state: Connecticut
city: Newark
country: United States
facility: Helen F. Graham Cancer Center
state: Delaware
city: Washington
country: United States
facility: Lombardi Cancer Center
state: District of Columbia
city: Washington
country: United States
facility: Walter Reid Army Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Miami Cancer Center
state: Florida
city: Miami
country: United States
facility: Urology Center of South Florida
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers of Florida
state: Florida
city: Port St. Lucie
country: United States
facility: Hematology/Oncology Associates of the Treasure Coast
state: Florida
city: Atlanta
country: United States
facility: Georgia Urology, P.A.
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Midwest Prostate & Urology Health Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Park Ridge
country: United States
facility: Lutheran General Cancer Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: Chesapeake Urology Associates
state: Maryland
city: Greenbelt
country: United States
facility: Myron I Murdock MD LLC
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic (Department of Urology)
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: West Orange
country: United States
facility: Associates in Urology, LLC
state: New Jersey
city: Albany
country: United States
facility: Albany Regional Cancer Center
state: New York
city: Albany
country: United States
facility: The Urological Institute of Northeastern New York
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology Oncology Associates
state: New York
city: Hawthorne
country: United States
facility: New York Medical College
state: New York
city: New York
country: United States
facility: Beth Israel Cancer Center
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: New York
country: United States
facility: Clinical Cancer Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Staten Island
country: United States
facility: Staten Island Urological Research
state: New York
city: Charlotte
country: United States
facility: McKay Urology
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: EACRI
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Medical Group
state: Oregon
city: Springfield
country: United States
facility: Oregon Urology Specialists
state: Oregon
city: Bryn Mawr
country: United States
facility: Center for Urologic Care
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Medical College
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Grand Strand Urology
state: South Carolina
city: Dallas
country: United States
facility: Mary Crowley
state: Texas
city: Fort Worth
country: United States
facility: Urology Associates of North Texas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Norfolk
country: United States
facility: Urology of Virginia, PC
state: Virginia
city: Norfolk
country: United States
facility: Urology of Virginia, PC
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Hospital Immunotherapy Program
state: Wisconsin
city: Victoria
country: Canada
facility: Can-Med Medical Research, Inc.
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Scarborough
country: Canada
facility: Urology CURC Scarborough
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook & Women's College HSC
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hospital Notre Dame du CHUM
state: Quebec
Study officials:
affiliation: Devine Tidewater Urology
name: Paul Schellhammer, MD
role: STUDY_CHAIR
References:
citation: Ju M, Fan J, Zou Y, Yu M, Jiang L, Wei Q, Bi J, Hu B, Guan Q, Song X, Dong M, Wang L, Yu L, Wang Y, Kang H, Xin W, Zhao L. Computational Recognition of a Regulatory T-cell-specific Signature With Potential Implications in Prognosis, Immunotherapy, and Therapeutic Resistance of Prostate Cancer. Front Immunol. 2022 Jun 23;13:807840. doi: 10.3389/fimmu.2022.807840. eCollection 2022.
citation: 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.
citation: 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.
citation: 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.