- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01133704
Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
September 2, 2010 updated by: Dendreon
A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Histologically documented adenocarcinoma of the prostate
- Metastatic disease as evidenced by soft tissue and/or bony metastases
- Prostate-specific antigen value of at least 5 ng/mL
- Tumor progression while on hormonal therapy
- Castration levels of testosterone (defined as less than 50 ng/dL)
- Life expectancy of at least 16 weeks
- Adequate hematologic, renal, and liver function
Exclusion Criteria:
- Visceral organ metastases
- Metastatic disease expected to be in need of radiation therapy within 4 months.
- Concurrent therapy with experimental agents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Active Comparator: sipuleucel-T (APC8015)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Time to Disease Progression
Time Frame: from randomization to 36 months
|
Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.
|
from randomization to 36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: Time from randomization until 36 months
|
Subjects were followed for 3 years from the time of randomization or until death.
|
Time from randomization until 36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2000
Primary Completion (Actual)
March 1, 2003
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
May 27, 2010
First Submitted That Met QC Criteria
May 28, 2010
First Posted (Estimate)
May 31, 2010
Study Record Updates
Last Update Posted (Estimate)
September 8, 2010
Last Update Submitted That Met QC Criteria
September 2, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D9902A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hormone-Refractory Prostate Cancer
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University of California, IrvineBristol-Myers SquibbCompletedRecurrent Prostate Cancer | Prostate Cancer | Hormone-resistant Prostate Cancer | Adenocarcinoma of the Prostate | Hormone-refractory Prostate CancerUnited States
-
DendreonCompletedHormone Refractory Prostate Cancer | Castration-resistant Prostate Cancer | Prostate Cancer MetastaticUnited States
-
Jiangsu HengRui Medicine Co., Ltd.UnknownHormone Refractory Prostate Cancer | Metastatic Prostate CarcinomaChina
-
National Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Hormone-refractory Prostate CancerUnited States
-
PfizerAstellas Pharma Inc; Medivation LLC, a wholly owned subsidiary of Pfizer Inc.CompletedProstate Cancer | Hormone Refractory Prostate CancerUnited States
-
Spanish Oncology Genito-Urinary GroupAstellas Pharma Inc; Apices Soluciones S.L.CompletedHormone-refractory Prostate CancerSpain
-
Peking UniversityWithdrawnHormone Refractory Prostate CancerChina
-
Tianjin Medical University Cancer Institute and...UnknownHormone Refractory Prostate CancerChina
-
CytoVac A/SCompletedHormone-refractory Prostate CancerDenmark
-
British Columbia Cancer AgencyCompletedHormone Refractory Prostate CancerCanada
Clinical Trials on sipuleucel-T
-
DendreonUniversity of California, San FranciscoCompleted
-
DendreonCompletedProstatic Neoplasms | Advanced Prostate CancerUnited States
-
DendreonTerminatedProstate CancerUnited States
-
DendreonNot yet recruitingMetastatic Castration-Resistant Prostate Cancer (mCRPC)
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Bayer; DendreonCompletedProstate CancerUnited States
-
University of Texas Southwestern Medical CenterCompletedmCRPC | Metastatic Castrate-resistant Prostate CancerUnited States
-
DendreonPRA Health SciencesActive, not recruitingAdenocarcinoma of the ProstateUnited States
-
DendreonCompletedProstate CancerUnited States
-
DendreonCompletedProstate Cancer | Prostate Neoplasms | Cancer of the Prostate | Neoplasms, Prostate | Prostatic Cancer | Neoplasms, Prostatic | Cancer of ProstateAustria, France, Netherlands, United Kingdom
-
DendreonCompletedProstate CancerUnited States, Canada