Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer
3 other identifiers
interventional
127
1 country
34
Brief Summary
Rationale: Vaccines may make the body build an immune response to kill tumor cells. It is not yet known if vaccine therapy is effective for prostate cancer. Purpose: Randomized phase III trial to determine the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 prostate-cancer
Started Nov 1999
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1999
CompletedFirst Submitted
Initial submission to the registry
July 5, 2000
CompletedFirst Posted
Study publicly available on registry
March 5, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2004
CompletedResults Posted
Study results publicly available
November 1, 2010
CompletedNovember 1, 2010
October 1, 2010
4.8 years
July 5, 2000
May 28, 2010
October 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Objective Disease Progression
The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).
36 months from randomization
Secondary Outcomes (1)
Overall Survival
From randomization to 36 months
Study Arms (2)
sipuleucel-T
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
Approximately one-third of the autologous quiescent antigen presenting cells (APCs) prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals.
Eligibility Criteria
You may qualify if:
- Metastatic disease as evidenced by soft tissue and/or bony metastases.
- Baseline PSA value of at least 5 ng/mL. All subjects must have stable or rising PSA.
- Tumor progression after hormonal therapy.
- Hormonal therapy consisting of castration by orchiectomy or LHRH agonists for treatment of prostate cancer. Castration levels of testosterone (\< 50 ng/dL) must be documented for all subjects including subjects who underwent orchiectomy as therapy for cancer of the prostate.
- A subject is eligible if he initially responded to antiandrogen withdrawal (\> 25% decrease in PSA) but at the time of registration demonstrated tumor progression. A subject is eligible if he failed to respond to antiandrogen withdrawal.
- Subjects have no cancer-related pain and do not regularly require analgesics for cancer-related pain.
- ECOG Performance Status of 0 or 1.
- Life expectancy of at least 16 weeks.
- Adequate hematologic, renal, and liver function.
You may not qualify if:
- Visceral organ metastases (e.g., liver, lung, brain) or cytologically positive effusions (e.g., pleural effusions or ascites).
- Metastatic disease expected to be in need of radiation therapy within 4 months.
- Concurrent therapy with experimental agents.
- Systemic corticosteroids at doses greater than 40 mg hydrocortisone per day for any reason other than treatment of prostate cancer within the previous 6 months without prior approval.
- Please note that there are additional eligibility criteria. The study center will determine if you meet all of the criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dendreonlead
Study Sites (34)
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Cancer and Blood Institute of the Desert
Rancho Mirage, California, 92270, United States
Eisenhower Medical Center
Rancho Mirage, California, 92270, United States
Sidney Kimmel Cancer Center
San Diego, California, 92121, United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128, United States
Office of Glenn Tisman
Whittier, California, 90601, United States
Office of Barry S. Berman
Orlando, Florida, 32806, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
St. Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956, United States
Albany Regional Cancer Center
Albany, New York, 12208, United States
Center for Medical Oncology
Garden City, New York, 11530, United States
St. Vincents Comprehensive Cancer Center
New York, New York, 10011, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016, United States
St. Luke's-Roosevelt Hospital
New York, New York, 10019, United States
New York Presbyterian Hospital - Cornell Campus
New York, New York, 10021, United States
University of Rochester Cancer Center
Rochester, New York, 14642, United States
Albert Einstein Comprehensive Cancer Center
The Bronx, New York, 10461, United States
New York Medical College
Valhalla, New York, 10595, United States
AKSM Clinical Research Corporation
Columbus, Ohio, 43214, United States
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, 97213-2967, United States
Abington Hematology Oncology Associates, Incorporated
Abington, Pennsylvania, 19001, United States
Bryn Mawr Urology
Bryn Mawr, Pennsylvania, 19010, United States
Office of Guy Bernstein, M.D.
Bryn Mawr, Pennsylvania, 19010, United States
Saint Mary Regional Cancer Center
Langhorne, Pennsylvania, 19047, United States
North Penn Hospital
Lansdale, Pennsylvania, 19446-1200, United States
Hematology/Oncology Associates of NE Pennsylvania, P.C.
Scranton, Pennsylvania, 18510, United States
American Oncology Resources
Dallas, Texas, 75246, United States
Devine Tidewater Urology
Norfolk, Virginia, 23507, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
Cancer Care Northwest
Spokane, Washington, 99202, United States
Hematology Oncology Northwest, P.C.
Tacoma, Washington, 98405, United States
Related Publications (4)
Higano CS, Schellhammer PF, Small EJ, Burch PA, Nemunaitis J, Yuh L, Provost N, Frohlich MW. Integrated data from 2 randomized, double-blind, placebo-controlled, phase 3 trials of active cellular immunotherapy with sipuleucel-T in advanced prostate cancer. Cancer. 2009 Aug 15;115(16):3670-9. doi: 10.1002/cncr.24429.
PMID: 19536890BACKGROUNDSmall EJ, Schellhammer PF, Higano CS, Redfern CH, Nemunaitis JJ, Valone FH, Verjee SS, Jones LA, Hershberg RM. Placebo-controlled phase III trial of immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic, asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006 Jul 1;24(19):3089-94. doi: 10.1200/JCO.2005.04.5252.
PMID: 16809734RESULTJu 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.
PMID: 35812443DERIVEDSmall 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.
PMID: 24957547DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathleen Picha
- Organization
- Dendreon Corporation
Study Officials
- STUDY CHAIR
Eric J. Small, MD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 5, 2000
First Posted
March 5, 2004
Study Start
November 1, 1999
Primary Completion
September 1, 2004
Study Completion
September 1, 2004
Last Updated
November 1, 2010
Results First Posted
November 1, 2010
Record last verified: 2010-10