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.
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.
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)
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
Cohort
Other
High Intensity Focused Ultrasound
DeviceUse 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.
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.
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.
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.
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.
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Sonablate
Lead sponsor
Indiana University
Collaborator
