A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer (PROCEED)
The purpose of this study is to further quantify the risk of cerebrovascular events (CVEs) following sipuleucel-T (PROVENGE®) therapy, and to follow all subjects for survival.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer|
- To further quantify the risk of cerebrovascular events following sipuleucel-T therapy for all subjects [ Time Frame: Every 3 months for a minimum of 3 years ] [ Designated as safety issue: Yes ]To further quantify the risk of cerebrovascular events following sipuleucel-T therapy for all subjects
- Survival [ Time Frame: Every 3 months for a minimum of 3 years ] [ Designated as safety issue: No ]To quantify survival in all subjects.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (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.
Other Name: PROVENGE, APC8015
Subjects will receive product as described in the sipuleucel-T approved label. The registry will be strictly observational and thus no additional clinical visits or laboratory tests will be conducted beyond normal clinical practice. Investigators will be asked to record information that becomes available in the normal course of clinical management.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01306890
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