Sonablate HIFU International Registry for PC & BPH Patients
Recruiting · NCT07757490 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sonablate
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Indiana University Medical Center - Indianapolis, Indiana, United States