An observational study in Localized Prostate Cancer, BPH (Benign Prostatic Hyperplasia) and Prostate Cancer; Benign Prostatic Hyperplasia, sponsored by Sonablate. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Sonablate · Observational
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.
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Sonablate is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult biological males (≥18 years) diagnosed with localized prostate cancer and/or benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS), who have undergone Sonablate HIFU ablation strictly as part of routine standard clinical care
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: High Intensity Focused Ultrasound
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.
Use of high intensity focused utrasound and sonatripsy for thermal and mechanical tissue ablation
Biochemical and Histological Recurrence-Free Survival Rate
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.
Time frame: Baseline, and annually up to 10 years
Change in International Prostate Symptom Score (IPSS) / AUA Symptom Score
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.
Time frame: Baseline, 3, 6, 12 months, and annually up to 10 years
Change in Erectile Function (SHIM / IIEF-5 Score)
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.
Time frame: Baseline, 3, 6, 12 months, and annually up to 10 years
Pad-Free Urinary Continence Rate
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.
Time frame: 3, 6, 12 months, and annually up to 10 years
Intraoperative Tissue Change Monitoring (TCM) Correlation
Correlation of intraoperative Tissue Change Monitoring (TCM) data with post-operative IPSS relief and PSA nadir to identify predictors of treatment success.
Time frame: Up to 10 years
Salvage-Free Survival
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.
Time frame: Up to 10 years
Number of Participants with Procedure-Related Adverse Events
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.
Time frame: Up to 10 years
Plan to share: No — Individual participant data (IPD) will not be shared externally. To strictly adhere to national and international data sovereignty laws, the registry operates under an independent Honest Broker framework. All centralized data is fully de-identified according to HIPAA Safe Harbor standards prior to transmission. Access to the aggregated database is strictly governed by legally binding Data Transfer Agreements (DTAs) and restricted exclusively to eligible participating clinical sites. Public or external sharing of individual-level data is explicitly prohibited to guarantee absolute patient privacy
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