Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (PRIME)
|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: NCT01727154|
Recruitment Status : Terminated (Administrative reasons)
First Posted : November 15, 2012
Results First Posted : August 19, 2019
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Biological: Sipuleucel-T|
|Study Type :||Observational|
|Actual Enrollment :||139 participants|
|Official Title:||Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
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.
- The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T). [ Time Frame: Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T. ]The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727154
Show 39 Study Locations
|Study Director:||Bruce Brown, MD||Dendreon Pharmaceuticals, LLC|