International Registry Observing Long-Term Outcomes of Sonablate HIFU Treatment for Localized Prostate Cancer and Benign Prostatic Hyperplasia in Men

What this Trial Is About

Researchers are evaluating the long-term safety and effectiveness of the Sonablate High-Intensity Focused Ultrasound HIFU system in adult men treated for localized prostate cancer, benign prostatic hyperplasia BPH with urinary symptoms, or both. This observational registry study collects real-world medical data from multiple clinics worldwide to better understand how well HIFU controls disease and affects urinary and sexual functions over 10 to 20 years. The goal is to improve treatment protocols and mens health knowledge. The study involves two participant groups one retrospective group of men previously treated with Sonablate HIFU and one prospective group of newly treated men receiving standard clinical care. No experimental treatments are assigned. Data from both groups are fully de-identified and securely sent to a central database at Indiana University. A mandatory 180-day delay after treatment is required before any new patient data can be included to protect privacy. Participants medical data include symptom scores, erectile function, urinary continence, tissue monitoring, and survival without recurrence, collected at baseline and regularly up to 10 years. An independent audit ensures patient privacy by reviewing a sample of the database annually. The study does not involve active treatment but tracks long-term outcomes of HIFU therapy in men treated as part of usual care, with data collection continuing until 2035.

Sonablate HIFU International Registry for PC & BPH Patients