Sonablate HIFU International Registry for PC & BPH Patients

NCT07757490 | Recruiting FDA Device

• 1 other identifier: SHIR012026
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Localized Prostate Cancer; BPH (Benign Prostatic Hyperplasia); Prostate Cancer; Benign Prostatic Hyperplasia

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, and annually up to 10 years

Secondary Outcomes (6)

• 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

Study Arms (2)

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.

Device: High Intensity Focused Ultrasound

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.

Interventions

High Intensity Focused Ultrasound DEVICE

Use of high intensity focused utrasound and sonatripsy for thermal and mechanical tissue ablation

Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonablate: lead
• Indiana University: collaborator

Study Sites (1)

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (6)

• Light 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 BACKGROUND

• Garcia-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 BACKGROUND

• Khandwala 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 BACKGROUND

• Guillaumier 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 BACKGROUND

• Koch 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.

  PMID: 17936800 BACKGROUND

• Shoji S, Naruse J, Ohno S, Aoki M, Takahashi K, Yuzuriha S, Kuroda S, Umemoto T, Nakajima N, Hasegawa M, Kawamura Y, Kajiwara H, Hashida K, Uemura K, Hasebe T, Tajiri T. Focal therapy using high-intensity focused ultrasound with intraoperative prostate compression for patients with localized prostate cancer: a multi-center prospective study with 7 year experience. Prostate Cancer Prostatic Dis. 2025 Sep;28(3):782-788. doi: 10.1038/s41391-024-00921-0. Epub 2024 Nov 23.

  PMID: 39580599 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Neoplasms; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clint D. Bahler, MD, MS

  Indiana University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clint D. Bahler, MD, MS

CONTACT

317-944-3458; cdbahler@iu.edu

K. Clinton Cary, MD, MPH

CONTACT

317-944-3458; kcary@iu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 11, 2026
• Study Start: January 1, 2015
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)