Back to resultsVaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
sipuleucel-T
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
Eligibility Criteria
Inclusion Criteria include: 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. Exclusion Criteria include: 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.
Sites / Locations
- Cancer Center and Beckman Research Institute, City of Hope
- Loma Linda University Medical Center
- Cancer and Blood Institute of the Desert
- Eisenhower Medical Center
- Sidney Kimmel Cancer Center
- UCSF Cancer Center and Cancer Research Institute
- Office of Glenn Tisman
- Office of Barry S. Berman
- Mayo Clinic Cancer Center
- Hackensack University Medical Center
- St. Barnabas Medical Center
- Morristown Memorial Hospital
- Albany Regional Cancer Center
- Albert Einstein Comprehensive Cancer Center
- Center for Medical Oncology
- St. Vincents Comprehensive Cancer Center
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- St. Luke's-Roosevelt Hospital
- New York Presbyterian Hospital - Cornell Campus
- University of Rochester Cancer Center
- New York Medical College
- AKSM Clinical Research Corporation
- Earle A. Chiles Research Institute at Providence Portland Medical Center
- Abington Hematology Oncology Associates, Incorporated
- Bryn Mawr Urology
- Office of Guy Bernstein, M.D.
- Saint Mary Regional Cancer Center
- North Penn Hospital
- Hematology/Oncology Associates of NE Pennsylvania, P.C.
- American Oncology Resources
- Devine Tidewater Urology
- Seattle Cancer Care Alliance
- Cancer Care Northwest
- Hematology Oncology Northwest, P.C.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
sipuleucel-T
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Overall Survival
Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00005947
Brief Title
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Official Title
A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge) for Asymptomatic Metastatic Hormome-Refractory Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Dendreon
4. Oversight
5. Study Description
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.
Detailed Description
Objectives:
I. Compare the time to progression, time to development of disease-related pain, and incidence of grade 3 or worse treatment-related adverse events in patients with asymptomatic metastatic hormone refractory adenocarcinoma of the prostate treated with APC8015 versus control infusion. II. Compare response rate and duration of response in these patients.
Outline: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Autologous dendritic cell precursors (ADCP) are harvested on weeks 0, 2, and 4. Patients receive APC8015 comprised of ADCP activated with prostatic acid phosphatase-sargramostim (GM-CSF) fusion protein IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions. Arm II: ADCP are harvested as in arm I. Patients receive unactivated ADCP IV over 30 minutes beginning 2 days after each harvest for a total of 3 infusions. Pain is assessed weekly for up to 3 years or until 4 weeks after objective disease progression. Patients are followed monthly for up to 3 years or until disease progression. At the time of disease progression, patients treated on arm II may receive treatment on Protocol D9903.
Projected Accrual: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IV prostate cancer, recurrent prostate cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sipuleucel-T
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
sipuleucel-T
Other Intervention Name(s)
APC8015, Provenge
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Objective Disease Progression
Description
The time to objective disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T).
Time Frame
36 months from randomization
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival
Time Frame
From randomization to 36 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria include:
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.
Exclusion Criteria include:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric J. Small, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Center and Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Cancer and Blood Institute of the Desert
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Eisenhower Medical Center
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Sidney Kimmel Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
Office of Glenn Tisman
City
Whittier
State/Province
California
ZIP/Postal Code
90601
Country
United States
Facility Name
Office of Barry S. Berman
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
St. Barnabas Medical Center
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962-1956
Country
United States
Facility Name
Albany Regional Cancer Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Albert Einstein Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Center for Medical Oncology
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
St. Vincents Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
NYU School of Medicine's Kaplan Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
St. Luke's-Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
New York Presbyterian Hospital - Cornell Campus
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
AKSM Clinical Research Corporation
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Earle A. Chiles Research Institute at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213-2967
Country
United States
Facility Name
Abington Hematology Oncology Associates, Incorporated
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Bryn Mawr Urology
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Office of Guy Bernstein, M.D.
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Saint Mary Regional Cancer Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
North Penn Hospital
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446-1200
Country
United States
Facility Name
Hematology/Oncology Associates of NE Pennsylvania, P.C.
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
Facility Name
American Oncology Resources
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Devine Tidewater Urology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
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
99202
Country
United States
Facility Name
Hematology Oncology Northwest, P.C.
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19536890
Citation
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.
Results Reference
background
PubMed Identifier
16809734
Citation
Small 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.
Results Reference
result
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
Learn more about this trial
Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
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