BPH (Benign Prostatic Hyperplasia), Localized Prostate Cancer, Prostate Cancer; Benign Prostatic Hyperplasia
Conditions
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
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.
Interventions
Use of high intensity focused utrasound and sonatripsy for thermal and mechanical tissue ablation
Sponsors
Sonablate
Indiana University
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemical and Histological Recurrence-Free Survival Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in International Prostate Symptom Score (IPSS) / AUA Symptom Score | 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. |
| Change in Erectile Function (SHIM / IIEF-5 Score) | 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. |
| Pad-Free Urinary Continence Rate | 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. |
| Intraoperative Tissue Change Monitoring (TCM) Correlation | 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. |
| Salvage-Free Survival | 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. |
| Number of Participants with Procedure-Related Adverse Events | 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. |
Countries
United States
Contacts
CONTACTClint D. Bahler, MD, MS
CONTACTK. Clinton Cary, MD, MPH
PRINCIPAL_INVESTIGATORClint D. Bahler, MD, MS
Indiana University Medical Center
Outcome results
None listed