Sonablate HIFU Registry for Prostate Cancer and BPH
Official title: SONAFUSION Registry (Long-term Evaluation of Sonablate High-Intensity Focused Ultrasound for the Treatment of Prostate Cancer and Benign Prostatic Hyperplasia)
Run by Sonablate · NCT07757490 · Data updated 2026-11-12
This registry collects real-world data from men treated with Sonablate HIFU to see how well it works and how it affects urinary and sexual function over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 10000 (estimated) |
| Sponsor | Sonablate Industry-sponsored |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | January 1, 2015 |
| Main results expected | December 2035 |
| Study ends | December 2035 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT07757490 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adult men with diagnosed localized prostate cancer or BPH who have undergone Sonablate HIFU ablation as part of standard clinical care and consent to de-identified data inclusion.
✕Probably not a fit
Patients not treated with HIFU or those with data that cannot be de-identified may not benefit from insights generated by the registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The SONA FUSION Registry is an observational, multi-center effort to document long-term outcomes after Sonablate High-Intensity Focused Ultrasound for localized prostate cancer, BPH, or both. It combines retrospective and prospective data from routine clinical care, with de-identified records and a 180-day post-procedure data delay to protect privacy. The study aims to refine treatment protocols and improve patient counseling, by tracking effectiveness, safety, and functional outcomes over 10 to 20 years. No experimental interventions are performed within the registry; it analyzes standard-of-care HIFU treatments across participating centers, led by Sonablate with collaboration from Indiana University. An independent Honest Broker audits a sample of data annually to ensure data integrity and privacy safeguards.
Why it matters
Potential benefit: If successful, the registry could improve understanding of long-term safety and effectiveness of HIFU, helping clinicians optimize patient selection and counseling.
How similar studies have gone: Prior work with HIFU devices has shown favorable short-to-mid-term outcomes; this registry extends evidence with long-term, real-world data, which is somewhat novel in scope.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Indiana University Medical Center
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: Clint D. Bahler, MD, MS — Indiana University Medical Center
- Study coordinator: Clint D. Bahler, MD, MS
- Email: cdbahler@iu.edu
- Phone: 317-944-3458
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.