At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,976 enrolled
Drug / intervention
sipuleucel-Tbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Registry of Sipuleucel-T Therapy in Men With Advanced Prostate Cancer
In Brief
An observational study evaluating sipuleucel-T for Advanced Prostate Cancer and Prostatic Neoplasms. Completed, enrolled 1,976 participants across 333 sites.
Detailed Summary
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 Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Prostate Cancer, Prostatic Neoplasms
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedMar 2011
Primary CompletionJan 2017
TodayJul 2026
First PostedMar 2, 2011
Enrollment StartJan 27, 2011
Primary CompletionJan 17, 2017
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 15.3 years ago
Interventions
sipuleucel-Tbiological
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.