Recruiting

HIFU

Sponsor:

Sonablate

Code:

NCT07757490

Conditions

Localized Prostate Cancer

BPH (Benign Prostatic Hyperplasia)

Prostate Cancer; Benign Prostatic Hyperplasia

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High Intensity Focused Ultrasound

Study Details

Brief 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.

Conditions

Localized Prostate Cancer

BPH (Benign Prostatic Hyperplasia)

Prostate Cancer; Benign Prostatic Hyperplasia

Study ID

NCT07757490

Start date

Jan 1, 2015

Status verified date

Aug, 2026

Completion date

Dec, 2035

Anticipated

Primary completion date

Dec, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

Retrospective Cohort

Historical, fully de-identified clinical data from patients treated for localized prostate cancer or BPH who underwent Sonablate HIFU ablation as part of standard clinical care.

Prospective Cohort

Newly treated prostate cancer or BPH patients undergoing Sonablate HIFU ablation as part of standard clinical care, subject to a mandatory 180-day post-procedure data abstraction delay.

Interventions

High Intensity Focused Ultrasound

Use of high intensity focused utrasound and sonatripsy for thermal and mechanical tissue ablation

Primary outcome measure

  • Biochemical and Histological Recurrence-Free Survival Rate [ Time Frame: Baseline, and annually up to 10 years ]

Central Contacts and Locations

Central contacts

Clint D. Bahler, MD, MS

317-944-3458cdbahler@iu.edu

K. Clinton Cary, MD, MPH

317-944-3458kcary@iu.edu

Locations

Indiana University Medical Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Clint D. Bahler, MD

317-944-3458cdbahler@iu.edu

More Information

Sponsor

Sonablate

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • HIFU, LOFU, High Intensity Focused Ultrasound, Sonablate, Directional Compression, Bolus Guide, prostate cancer, BPH, Histoblast, Sonatripsy
  • High-Intensity Focused Ultrasound, HIFU, Sonablate, Lower Urinary Tract Symptoms, Minimally Invasive, Prostate Ablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Sonablate on 2026-08-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.