Prostate Cancer Clinical Trial
Official title:
An Open-Label Study Study of Sipuleucel-T in European Men With Metastatic, Castrate Resistant Prostate Cancer
To demonstrate that sipuleucel-T can be successfully manufactured for subjects with metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.
This was an open-label, uncontrolled, multi-center study. Study participants will underwent
screening procedures to ensure that they met the inclusion and exclusion criteria. Subjects
underwent a standard 1.5 to 2.0 blood volume leukapheresis, followed approximately 3 days
later by an infusion of sipuleucel-T. This process was be repeated at approximately 2-week
intervals for a total of 3 infusions.
In Austria, The Netherlands, and France, a study completion visit occurred between 30 and 37
days post-final infusion, or between 30 and 37 days post-final leukapheresis for subjects
not receiving at least 1 infusion. In the UK, a follow-up visit occurred 30 days after the
subject's final infusion and a study completion visit occurred 6 months after the subject's
final infusion.
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Intervention Model: Single Group Assignment, Masking: Open Label
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