SONAFUSION Registry (Long-term Evaluation of Sonablate High-Intensity Focused Ultrasound for the Treatment of Prostate Cancer and Benign Prostatic Hyperplasia)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 10,000
- Locations
- 1
- Primary Endpoint
- Biochemical and Histological Recurrence-Free Survival Rate
Study Overview
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: High Intensity Focused Ultrasound (Device)
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.
Outcomes
Primary Outcomes
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
- Change in International Prostate Symptom Score (IPSS) / AUA Symptom Score(Baseline, 3, 6, 12 months, and annually up to 10 years)
- Change in Erectile Function (SHIM / IIEF-5 Score)(Baseline, 3, 6, 12 months, and annually up to 10 years)
- Pad-Free Urinary Continence Rate(3, 6, 12 months, and annually up to 10 years)
- Intraoperative Tissue Change Monitoring (TCM) Correlation(Up to 10 years)
- Salvage-Free Survival(Up to 10 years)
- Number of Participants with Procedure-Related Adverse Events(Up to 10 years)