Back to resultsProvenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sipuleucel-T
APC-Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring 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
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.
Sites / Locations
- South Orange County Urological
- LLUMC for Molecular Biology and Gene Therapy
- USC Keck School of Medicine
- UCLA
- Comprehensive Cancer Center
- Sutter Cancer Center
- Kaiser Permanente Medical Group
- Sharp HealthCare
- UCSF Cancer Center
- Rocky Mountain Cancer Center
- Connecticut Urological Research at Grove Hill
- Helen F. Graham Cancer Center
- Lombardi Cancer Center
- Walter Reid Army Medical Center
- Miami Cancer Center
- Urology Center of South Florida
- Cancer Centers of Florida
- Hematology/Oncology Associates of the Treasure Coast
- Georgia Urology, P.A.
- Rush University Medical Center
- Midwest Prostate & Urology Health Center
- Loyola University
- Lutheran General Cancer Center
- Indiana University
- Chesapeake Urology Associates
- Myron I Murdock MD LLC
- Dana-Farber Cancer Institute
- Lahey Clinic (Department of Urology)
- University of Minnesota
- Mayo Clinic
- Nevada Cancer Institute
- Hackensack University Medical Center
- Associates in Urology, LLC
- Albany Regional Cancer Center
- The Urological Institute of Northeastern New York
- North Shore Hematology Oncology Associates
- New York Medical College
- Beth Israel Cancer Center
- New York University
- Clinical Cancer Center
- Mount Sinai School of Medicine
- Staten Island Urological Research
- McKay Urology
- Duke University Medical Center
- University of Cincinnati
- Cleveland Clinic Foundation
- EACRI
- Kaiser Permanente Medical Group
- Oregon Urology Specialists
- Center for Urologic Care
- Jefferson Medical College
- Grand Strand Urology
- Mary Crowley
- Urology Associates of North Texas
- Baylor College of Medicine
- University of Utah
- Urology of Virginia, PC
- Urology of Virginia, PC
- Virginia Mason Medical Center
- Seattle Cancer Care Alliance
- Cancer Care Northwest
- Wenatchee Valley Medical Center
- University of Wisconsin, Madison
- University of Wisconsin
- St. Luke's Hospital Immunotherapy Program
- Can-Med Medical Research, Inc.
- London Health Sciences Centre
- Urology CURC Scarborough
- Sunnybrook & Women's College HSC
- Princess Margaret Hospital
- Hospital Notre Dame du CHUM
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
APC-Placebo
Sipuleucel-T
Arm Description
Outcomes
Primary Outcome Measures
Overall Survival
Time from randomization until death due to any cause.
Secondary Outcome Measures
Time to Objective Disease Progression
Measured by imaging studies; confirmed by independent imaging review
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00065442
Brief Title
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
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dendreon
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
512 (Actual)
8. Arms, Groups, and Interventions
Arm Title
APC-Placebo
Arm Type
Placebo Comparator
Arm Title
Sipuleucel-T
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Sipuleucel-T
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
APC-Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Time from randomization until death due to any cause.
Time Frame
Event-driven timeframe. Final analysis at 331 events.
Secondary Outcome Measure Information:
Title
Time to Objective Disease Progression
Description
Measured by imaging studies; confirmed by independent imaging review
Time Frame
Analysis conducted at the time of overall survival analysis
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Schellhammer, MD
Organizational Affiliation
Devine Tidewater Urology
Official's Role
Study Chair
Facility Information:
Facility Name
South Orange County Urological
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
LLUMC for Molecular Biology and Gene Therapy
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
USC Keck School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9178
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1738
Country
United States
Facility Name
Comprehensive Cancer Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
982262
Country
United States
Facility Name
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Sharp HealthCare
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Connecticut Urological Research at Grove Hill
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Helen F. Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Facility Name
Walter Reid Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307
Country
United States
Facility Name
Miami Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Urology Center of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Cancer Centers of Florida
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Hematology/Oncology Associates of the Treasure Coast
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Georgia Urology, P.A.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Midwest Prostate & Urology Health Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Lutheran General Cancer Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Chesapeake Urology Associates
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Myron I Murdock MD LLC
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115-6084
Country
United States
Facility Name
Lahey Clinic (Department of Urology)
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Associates in Urology, LLC
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Facility Name
Albany Regional Cancer Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
The Urological Institute of Northeastern New York
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
North Shore Hematology Oncology Associates
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
New York Medical College
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Beth Israel Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Staten Island Urological Research
City
Staten Island
State/Province
New York
ZIP/Postal Code
10304
Country
United States
Facility Name
McKay Urology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0502
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
EACRI
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227-1191
Country
United States
Facility Name
Oregon Urology Specialists
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Center for Urologic Care
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Jefferson Medical College
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Grand Strand Urology
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Mary Crowley
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Urology Associates of North Texas
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Urology of Virginia, PC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Urology of Virginia, PC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
University of Wisconsin, Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
St. Luke's Hospital Immunotherapy Program
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Can-Med Medical Research, Inc.
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Urology CURC Scarborough
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1S 4V5
Country
Canada
Facility Name
Sunnybrook & Women's College HSC
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hospital Notre Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
35812443
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.
Results Reference
derived
PubMed Identifier
24957547
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.
Results Reference
derived
PubMed Identifier
23253957
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.
Results Reference
derived
PubMed Identifier
20818862
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.
Results Reference
derived
Links:
URL
http://www.pcacoalition.org
Description
National Prostate Cancer Coalition
URL
http://www.ustoo.com
Description
USTOO International
Learn more about this trial
Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy
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