Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T (PRIME)
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T|
- To evaluate the immune response following sipuleucel-T therapy for all subjects [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]To evaluate the immune response following sipuleucel-T therapy for all subjects
Biospecimen Retention: Samples With DNA
Whole blood, serum, manufacturing samples
|Study Start Date:||October 2012|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
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.
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|Study Director:||Candice McCoy, MD||Dendreon|