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Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (PRIME)

This study has been terminated.
(Completion of 3yr follow up)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01727154
First Posted: November 15, 2012
Last Update Posted: July 11, 2017
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.
Information provided by (Responsible Party):
Dendreon
November 12, 2012
November 15, 2012
July 11, 2017
October 2012
January 2022   (Final data collection date for primary outcome measure)
To evaluate the immune response following sipuleucel-T therapy for all subjects [ Time Frame: up to 52 weeks ]
To evaluate the immune response following sipuleucel-T therapy for all subjects
Same as current
Complete list of historical versions of study NCT01727154 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).
Subjects will receive sipuleucel-T, and potentially other medications, as part of the clinical trial in which they are concurrently enrolled. For this study, cellular and humoral immune responses will be assessed. No additional study treatments will be conducted beyond what is required for the subject's concurrent clinical trial.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Whole blood, serum, manufacturing samples
Non-Probability Sample
Men at least 18 years of age with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT), and have not yet undergone leukapheresis for their first dose of sipuleucel-T.
Prostate Cancer
Biological: Sipuleucel-T
Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
Other Names:
  • PROVENGE
  • APC8015
Sipuleucel-T
Intervention: Biological: Sipuleucel-T
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
52
January 2022
January 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must be at least 18 years of age
  • Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT)
  • Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T
  • Subjects must understand and sign an informed consent form prior to their first leukapheresis

Exclusion Criteria:

•None

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01727154
P11-4
No
Not Provided
Not Provided
Dendreon
Dendreon
Not Provided
Study Director: Robert Israel, MD Valeant Pharmaceuticals North America LLC
Dendreon
July 2017