Study of Men with Metastatic Castrate-Resistant Prostate Cancer Treated with PROVENGE and Given a Single Booster Infusion of Sipuleucel-T to Measure Immune Response

What this Trial Is About

This trial focuses on men with metastatic castrate-resistant prostate cancer mCRPC who have previously been treated with PROVENGE4 immunotherapy. The study aims to investigate changes in immune responses following a booster dose of sipuleucel-T, an immunotherapy treatment. The trial is a phase 2, multicenter, open-label study designed to better understand immune boost responses in this patient group. Participants who have completed their initial treatment with PROVENGE4 will be randomly assigned to one of two groups one group will receive a single booster infusion of sipuleucel-T approximately 6 to 9 months after their initial treatment, while the other group will not receive any additional intervention. The sipuleucel-T is delivered as an intravenous infusion. Both groups will be monitored according to the study schedule. Throughout the study, participants will undergo evaluations to measure immune responses to specific prostate cancer antigens after the booster infusion. Researchers will also monitor adverse events and overall survival over a 5-year period. The study involves regular follow-up visits to assess safety and immune activity, with total participation lasting up to five years after treatment.

Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T