A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer (PROCEED)
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|ClinicalTrials.gov Identifier: NCT01306890|
Recruitment Status : Completed
First Posted : March 2, 2011
Last Update Posted : April 24, 2017
|Condition or disease||Intervention/treatment|
|Advanced Prostate Cancer Prostatic Neoplasms||Biological: sipuleucel-T|
|Study Type :||Observational|
|Actual Enrollment :||1973 participants|
|Official Title:||A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer|
|Actual Study Start Date :||January 27, 2011|
|Actual Primary Completion Date :||January 17, 2017|
|Actual Study Completion Date :||January 17, 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.
Other Name: PROVENGE, APC8015
- 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 ]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 ]To quantify survival in all subjects.
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): NCT01306890
Show 333 Study Locations
|Study Director:||Robert Israel, MD||Valeant Pharmaceuticals North America LLC|