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Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01133704
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : September 2, 2010
Last Update Posted : September 8, 2010
Sponsor:
Information provided by:
Dendreon

Tracking Information
First Submitted Date  ICMJE May 27, 2010
First Posted Date  ICMJE May 31, 2010
Results First Submitted Date  ICMJE June 1, 2010
Results First Posted Date  ICMJE September 2, 2010
Last Update Posted Date September 8, 2010
Study Start Date  ICMJE May 2000
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 17, 2010)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 28, 2010)
Compare the overall time to disease progression [ Time Frame: from randomization to 36 months ]
To compare the overall time to disease progression in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T) to those treated with the control infusion.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2010)
Overall Survival [ Time Frame: Time from randomization until 36 months ]
Subjects were followed for 3 years from the time of randomization or until death.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2010)
Overall Survival [ Time Frame: From randomization through 36 months ]
To compare overall survival in patients with asymptomatic metastatic hormone-refractory prostate cancer treated with APC8015 (sipuleucel-T) to those treated with the control infusion.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Official Title  ICMJE A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hormone-Refractory Prostate Cancer
Intervention  ICMJE
  • Biological: sipuleucel-T
  • Biological: APC-Placebo
Study Arms  ICMJE
  • Active Comparator: sipuleucel-T (APC8015)
    Intervention: Biological: sipuleucel-T
  • Placebo Comparator: Placebo
    Intervention: Biological: APC-Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2010)
98
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Actual Primary Completion Date March 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01133704
Other Study ID Numbers  ICMJE D9902A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Dendreon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Dendreon
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP