Collecting Clinical Data on Men Treated for Prostate Cancer Using High Intensity Focused Ultrasound with the Focal One Device

What this Trial Is About

This research aims to collect real-life clinical data to evaluate the safety and performance of medical devices used in treating prostate cancer. Specifically, it focuses on patients who have received High Intensity Focused Ultrasound HIFU treatment using the Focal One device. The study is both prospective and retrospective, gathering information over several years to better understand treatment outcomes. Participants are men treated for prostate cancer with the Focal One HIFU device. The study involves monitoring from the time of HIFU treatment up to five years afterward. Throughout this period, data will be collected on prostate-specific antigen PSA levels, prostate MRI findings for local cancer recurrence, biopsy results, and any retreatment rates to assess ongoing treatment safety and effectiveness. Participants will contribute data over a follow-up period extending up to five years after their HIFU treatment. Researchers will collect and review clinical information, imaging results, and laboratory tests. The primary focus is on monitoring safety outcomes related to the HIFU procedure. This long-term observation aims to provide a comprehensive understanding of treatment effects and patient health over time.

Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.