Clinical trial · Observational
Sonablate HIFU International Registry for PC & BPH Patients
SONAFUSION Registry (Long-term Evaluation of Sonablate High-Intensity Focused Ultrasound for the Treatment of Prostate Cancer and Benign Prostatic Hyperplasia)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BPH (Benign Prostatic Hyperplasia) | Benign Prostatic Hyperplasia | ALIAS | 0.85 |
| Localized Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Prostate Cancer; Benign Prostatic Hyperplasia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Intensity Focused Ultrasound | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective Cohort
- description
- 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.
- interventionNames
- Device: High Intensity Focused Ultrasound
- label
- Prospective Cohort
- description
- 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.
Primary outcomes (1)
- measure
- Biochemical and Histological Recurrence-Free Survival Rate
- timeFrame
- Baseline, and annually up to 10 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDLight A, Peters M, Gopalakrishnan A, Mayor N, Cullen E, Boaz RJ, Norris JM, Morris S, Arya M, Tanaka MB, Doherty A, Dudderidge T, Emara A, Emberton M, Grey A, Hindley R, Laniado M, McCraken S, Moore CM, Nigam R, Noureldin M, Orczyk C, Rakauskas A, Simmons L, Virdi J, Withington J, Zakikhani P, Ahmed HU, Shah TT. Oncological Outcomes Following Focal HIFU and Cryotherapy for Treatment of Nonmetastatic Prostate Cancer in the United Kingdom: An Updated Analysis of 3477 Patients from the Prospective HEAT and ICE Registries. Eur Urol. 2026 Jul 10:S0302-2838(26)02169-X. doi: 10.1016/j.eururo.2026.05.007. Online ahead of print. PMID 42431756
- BACKGROUNDGarcia-Gutierrez CM, Garcia-Becerra CA, Garcia-Becerra N, Becerra-Herrejon H, Shoji S, Sanghvi NT. Histoblast: A Novel Cavitative High-Intensity Focused Ultrasound (HIFU)-Modified Technique for Benign Prostatic Hyperplasia. Cureus. 2025 Dec 11;17(12):e98989. doi: 10.7759/cureus.98989. eCollection 2025 Dec. PMID 41523515
- BACKGROUNDKhandwala YS, Soerensen SJC, Morisetty S, Ghanouni P, Fan RE, Vesal S, Rusu M, Sonn GA. The Association of Tissue Change and Treatment Success During High-intensity Focused Ultrasound Focal Therapy for Prostate Cancer. Eur Urol Focus. 2023 Jul;9(4):584-591. doi: 10.1016/j.euf.2022.10.010. Epub 2022 Nov 10. PMID 36372735
- BACKGROUNDGuillaumier S, Peters M, Arya M, Afzal N, Charman S, Dudderidge T, Hosking-Jervis F, Hindley RG, Lewi H, McCartan N, Moore CM, Nigam R, Ogden C, Persad R, Shah K, van der Meulen J, Virdi J, Winkler M, Emberton M, Ahmed HU. A Multicentre Study of 5-year Outcomes Following Focal Therapy in Treating Clinically Significant Nonmetastatic Prostate Cancer. Eur Urol. 2018 Oct;74(4):422-429. doi: 10.1016/j.eururo.2018.06.006. Epub 2018 Jun 28. PMID 29960750
- BACKGROUNDKoch MO, Gardner T, Cheng L, Fedewa RJ, Seip R, Sanghvi NT. Phase I/II trial of high intensity focused ultrasound for the treatment of previously untreated localized prostate cancer. J Urol. 2007 Dec;178(6):2366-70; discussion 2370-1. doi: 10.1016/j.juro.2007.08.014. Epub 2007 Oct 22.