Sonablate HIFU International Registry for PC & BPH Patients

NCT07757490 · tracked via the Priya Life Science USA tracker

Sponsor

Sonablate

Phase

Observational

Started

2015-01-01

Last updated

2026-08-13

Condition(s) studied

Localized Prostate CancerBPH (Benign Prostatic Hyperplasia)Prostate Cancer; Benign Prostatic Hyperplasia

Investigational drug(s) / intervention(s)

High Intensity Focused Ultrasound

High Intensity Focused Ultrasound: Use of high intensity focused utrasound and sonatripsy for thermal and mechanical tissue ablation

Study summary

The SONA FUSION Registry is an observational study designed to evaluate the long-term effectiveness and safety of the Sonablate High-Intensity Focused Ultrasound (HIFU) system. This study focuses on adult men who have been treated for localized prostate cancer, benign prostatic hyperplasia (BPH) with urinary symptoms, or a combination of both conditions. The registry collects real-world medical data from multiple clinics globally to better understand how well the HIFU treatment controls disease and affects urinary and sexual function over a 10- to 20-year period.

The study includes two groups of participants: a retrospective group of patients who previously received treatment, and a prospective group of newly treated patients receiving standard clinical care. No experimental interventions are assigned for the purpose of this study. To protect participant privacy, all medical data is completely de-identified and stripped of direct identifiers before being securely transferred to the central coordinating center at Indiana University. The ultimate goal of this research is to improve patient care protocols, advance men's health knowledge, and establish evidence-based guidelines for minimally invasive prostate treatments.

Eligibility

Sex

MALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Male with diagnosed localized prostate cancer or BPH (benign prostatic hyperplasia) * Having undergone Sonablate HIFU ablation as part of standard clinical care, with all central data transmission subject to a mandatory 180-day post-procedure delay. Exclusion Criteria: * Prostate size or lesion location precluding effective HIFU target acquisition (prostate volume \>100 CC for prostate cancer or \>80 CC for BPH) * Confirmed metastatic prostate cancer * Prior radical prostatectomy * Prostates with large calcifications (\>10mm causing shadowing) * Prior rectal wall surgery or inability to undergo transrectal ultrasound

Primary outcome measure(s)

Biochemical and Histological Recurrence-Free Survival Rate — Baseline, and annually up to 10 years
Proportion of patients remaining free of clinically significant prostate cancer recurrence in the treated area, evaluated via standard-of-care Prostate Specific Antigen (PSA) testing, multiparametric MRI, and/or follow-up prostate biopsy.

Trial sites (1)

Facility	City	Region	Status
Indiana University Medical Center	Indianapolis	Indiana	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07757490 on ClinicalTrials.gov ↗ ← All trials in the USA