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NCT Number: NCT07757490

Sonablate HIFU International Registry for PC & BPH Patients

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.

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Key information

Conditions

Localized Prostate Cancer BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Lower Urinary Tract Symptoms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Prostate Cancer; Benign Prostatic Hyperplasia Prostatic Diseases Prostatic Hyperplasia Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Urological Manifestations

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Clint D. Bahler, MD

CONTACT

[email protected]

317-944-3458

About this study

Traditional surgical interventions for prostate cancer and benign prostatic hyperplasia (BPH) are often associated with significant morbidity. While high-intensity focused ultrasound (HIFU) has emerged as a recognized, minimally invasive alternative, existing clinical evidence often lacks prospective, long-term follow-up and standardized, validated outcome assessments.

To systematically track and evaluate these standard-of-care interventions, the SONA FUSION Registry serves as a central repository for the consolidation of real-world clinical data from leading academic and clinical centers globally. The registry is designed to refine HIFU treatment protocols, improve patient counseling practices, and establish evidence-based scientific foundations for the standardized adoption of robotic HIFU technology.

The central repository at Indiana University receives and maintains exclusively de-identified research data. The protocol structurally prevents re-identification by mandating the permanent removal of all direct identifiers at the local site level prior to transmission. Furthermore, clinical dates are strictly protected via temporal masking, converting all temporal data to relative study days-and a non-negotiable 180-day post-procedure delay is enforced before any prospective data is authorized for abstraction.

To continuously validate these safeguards, an independent Honest Broker conducts an annual audit of a 20 percent sample of the database, ensuring the central research team remains definitively blinded to all patient identifiers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Focused Ultrasound

Device

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

Primary outcomes

  1. Biochemical and Histological Recurrence-Free Survival Rate

    Time frame: 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.

Secondary outcomes

  1. Change in International Prostate Symptom Score (IPSS) / AUA Symptom Score

    Time frame: Baseline, 3, 6, 12 months, and annually up to 10 years

    Assessment of lower urinary tract symptoms (LUTS) for both prostate cancer and BPH patients. The IPSS/AUASS consists of 7 questions regarding urinary symptoms. Total scores range from 0 to 35. A score of 0-7 indicates mild symptoms, 8-19 moderate symptoms, and 20-35 severe symptoms. Higher scores indicate worse urinary outcomes.

  2. Change in Erectile Function (SHIM / IIEF-5 Score)

    Time frame: Baseline, 3, 6, 12 months, and annually up to 10 years

    Erectile function and ability to maintain an erection satisfactory for penetration assessed via the Sexual Health Inventory for Men (SHIM), also known as the IIEF-5. Total scores range from 1 to 25. A score of 22-25 indicates normal erectile function, while scores of 21 or below indicate varying degrees of erectile dysfunction. Lower scores indicate worse sexual function outcomes.

  3. Pad-Free Urinary Continence Rate

    Time frame: 3, 6, 12 months, and annually up to 10 years

    Proportion of patients achieving complete pad-free urinary continence following HIFU treatment, clinically defined as the use of zero absorbent pads per day for urinary leakage.

  4. Intraoperative Tissue Change Monitoring (TCM) Correlation

    Time frame: Up to 10 years

    Correlation of intraoperative Tissue Change Monitoring (TCM) data with post-operative IPSS relief and PSA nadir to identify predictors of treatment success.

  5. Salvage-Free Survival

    Time frame: Up to 10 years

    Time from the primary Sonablate HIFU procedure (index date) to the initiation of any post-ablation salvage treatment (e.g., radical prostatectomy, radiation therapy, systemic therapy, or repeat HIFU ablation), evaluated via time-to-event longitudinal survival analysis.

  6. Number of Participants with Procedure-Related Adverse Events

    Time frame: Up to 10 years

    Number of participants experiencing urological, functional, or rectal complications post-HIFU, extracted from de-identified medical records following a mandatory 180-day abstraction delay. Severity is graded via the Clavien-Dindo system (Grade I [minor] to Grade V [death]), where higher grades indicate greater severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Clint D. Bahler, MD, MS

CONTACT

[email protected]

317-944-3458

K. Clinton Cary, MD, MPH

CONTACT

[email protected]

317-944-3458

Sponsors and collaborators

Lead sponsor

Sonablate

Industry

Collaborators

  • Indiana University

Registry information

Official study title

SONA FUSION Registry (Long-term Evaluation of Sonablate High-Intensity Focused Ultrasound for the Treatment of Prostate Cancer and Benign Prostatic Hyperplasia)

Acronym: SONA FUSION

Important dates

Study start
2015
Primary completion
2035
Study completion
2035
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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