Provenge® (Sipuleucel-T) Active Cellular Immunotherapy Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

This study has been completed.
Sponsor:
Information provided by:
Dendreon
ClinicalTrials.gov Identifier:
NCT00065442
First received: July 23, 2003
Last updated: September 2, 2010
Last verified: September 2010
Results First Received: May 28, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Biological: Sipuleucel-T
Biological: APC-Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were randomized between August 2003 and November 2007 across 75 clinical trial sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures.

Reporting Groups
  Description
APC-Placebo All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
Sipuleucel-T All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.

Participant Flow:   Overall Study
    APC-Placebo     Sipuleucel-T  
STARTED     171     341  
COMPLETED     46     121  
NOT COMPLETED     125     220  
Lost to Follow-up                 1                 1  
Death                 121                 210  
Withdrawal by Subject                 3                 9  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
APC-Placebo All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
Sipuleucel-T All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
Total Total of all reporting groups

Baseline Measures
    APC-Placebo     Sipuleucel-T     Total  
Number of Participants  
[units: participants]
  171     341     512  
Age  
[units: years]
Mean ± Standard Deviation
  70.1  ± 9.0     71.1  ± 8.9     70.8  ± 8.9  
Age, Customized  
[units: years]
Median ( Full Range )
  70  
  ( 40 to 89 )  
  72  
  ( 49 to 91 )  
  71  
  ( 40 to 91 )  
Gender  
[units: participants]
     
Female     0     0     0  
Male     171     341     512  



  Outcome Measures
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1.  Primary:   Overall Survival   [ Time Frame: Event-driven timeframe. Final analysis at 331 events. ]

2.  Secondary:   Time to Objective Disease Progression   [ Time Frame: Analysis conducted at the time of overall survival analysis ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Kathleen Picha
Organization: Dendreon Corporation
phone: 206-274-6762
e-mail: kpicha@dendreon.com


No publications provided by Dendreon

Publications automatically indexed to this study:

Responsible Party: Liz Smith, Dendreon Corporation
ClinicalTrials.gov Identifier: NCT00065442     History of Changes
Obsolete Identifiers: NCT00084760
Other Study ID Numbers: D9902B
Study First Received: July 23, 2003
Results First Received: May 28, 2010
Last Updated: September 2, 2010
Health Authority: United States: Food and Drug Administration