At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 47 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.
An Open-Label Study Study of Sipuleucel-T in European Men With Metastatic, Castrate Resistant Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating sipuleucel-T for Cancer of Prostate and 6 related conditions. Completed, enrolled 47 participants across 4 sites in 4 countries.
Detailed Summary
To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCancer of Prostate, Cancer of the Prostate, Neoplasms, Prostate, Neoplasms, Prostatic, Prostate Cancer, Prostate Neoplasms, Prostatic Cancer
CountriesAustria, France, Netherlands, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartJun 2012
Primary CompletionJun 2014
TodayJul 2026
First PostedNov 23, 2011
Enrollment StartJun 1, 2012
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.6 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.