{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,23]],"date-time":"2026-07-23T23:01:18Z","timestamp":1784847678377,"version":"3.55.0"},"reference-count":34,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2025,10,25]],"date-time":"2025-10-25T00:00:00Z","timestamp":1761350400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Karl Landsteiner University of Health Sciences, Krems, Austria","award":["SF34"],"award-info":[{"award-number":["SF34"]}]},{"name":"N\u00d6 Landesgesundheitsagentur, legal entity of University Hospitals in Lower Austria"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background\/Objectives: Whole-gland surgery or radiotherapy for localized prostate cancer (PCa) can cure the disease but often impair urinary and sexual function. Focal therapy with high-intensity focused ultrasound (HIFU) seeks to eradicate the tumor while sparing uninvolved tissue. We prospectively evaluated oncological control, functional outcomes and safety of MRI-guided focal HIFU in patients with low- or intermediate-risk PCa. Methods: In this prospective, single-arm, phase II feasibility trial (three Austrian centres, 2021\u20132024), treatment-naive patients with D\u2019Amico low\/intermediate-risk, PSA \u2264 15 ng\/mL, clinical stage \u2264 T2 and MRI-targeted, biopsy-confirmed index lesions underwent lesion-targeted HIFU (Focal One\u2122). The primary endpoint was failure-free survival (FFS: absence of salvage whole-gland or systemic therapy, metastasis or PCa-specific death). Secondary endpoints included biopsy-proven cancer, prostate-specific antigen (PSA), patient-reported symptoms as International Prostate Symptom Score (IPSS), 5-item International Index of Erectile Function (IIEF), Gaudenz Incontinence Questionnaire and adverse events. Planned follow-up was 24 months with PSA every 3 months, mpMRI and biopsies at 12 months, and imaging- or PSA-triggered biopsies thereafter. Results: Fifty-one men were analysed in the per-protocol cohort (median age 67 years, median PSA 7.55 ng\/mL). Median treated volume was 12 mL; median procedure time 85 min. At 24 months, FFS was 94.1%: 3\/51 patients (5.9%) required salvage radiotherapy. Among 31 patients who underwent follow-up biopsy, 26 (83.9%) had no cancer; the five positives included three ISUP 1, one ISUP2 and one ISUP 4 lesion. Mean PSA fell by 69% at 3 months (to 2.3 ng\/mL) and then stabilized under 3 ng\/mL, with a mean of 2.7 \u00b1 1.5 ng\/mL at 24 months. Transient acute urinary retention occurred in 11\/51 (21.6%); no Clavien\u2013Dindo grade \u2265 4 events were reported. IPSS returned to or improved beyond baseline, erectile function largely recovered by 6\u201312 months, and only one new case of grade 2 incontinence was observed. Conclusions: MRI-guided focal HIFU achieved high two-year failure-free survival with low morbidity and preserved quality of life in carefully selected patients with low- or intermediate-risk PCa. These data support further randomized and longer-term investigations of focal HIFU as an organ-sparing alternative to whole-gland treatment.<\/jats:p>","DOI":"10.3390\/cancers17213429","type":"journal-article","created":{"date-parts":[[2025,10,28]],"date-time":"2025-10-28T13:59:36Z","timestamp":1761659976000},"page":"3429","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Focal Therapy Using High-Intensity Focused Ultrasound for Low- and Intermediate-Risk Prostate Cancer: Results from a Prospective, Multicenter Feasibility Trial"],"prefix":"10.3390","volume":"17","author":[{"given":"Gabor","family":"Rosta","sequence":"first","affiliation":[{"name":"Division of Urology and Andrology, University Hospital St. P\u00f6lten, 3100 St. P\u00f6lten, Austria"},{"name":"Karl Landsteiner University of Health Sciences, 3500 Krems, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Simon","family":"Turba","sequence":"additional","affiliation":[{"name":"Division of Urology and Andrology, University Hospital St. P\u00f6lten, 3100 St. P\u00f6lten, Austria"},{"name":"Karl Landsteiner University of Health Sciences, 3500 Krems, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dong-Ho","family":"Mun","sequence":"additional","affiliation":[{"name":"Division of Urology and Andrology, University Hospital St. P\u00f6lten, 3100 St. P\u00f6lten, Austria"},{"name":"Karl Landsteiner University of Health Sciences, 3500 Krems, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Azad","family":"Shehab","sequence":"additional","affiliation":[{"name":"Division of Urology and Andrology, University Hospital St. P\u00f6lten, 3100 St. P\u00f6lten, Austria"},{"name":"Karl Landsteiner University of Health Sciences, 3500 Krems, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leon","family":"Saciri","sequence":"additional","affiliation":[{"name":"Division of Urology and Andrology, University Hospital St. P\u00f6lten, 3100 St. P\u00f6lten, Austria"},{"name":"Karl Landsteiner University of Health Sciences, 3500 Krems, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul F.","family":"Engelhardt","sequence":"additional","affiliation":[{"name":"Urology Department, Landesklinikum Baden, 2500 Baden, Austria"},{"name":"Paracelsus Private University, 5020 Salzburg, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia","family":"Weisz","sequence":"additional","affiliation":[{"name":"Urology Department, Landesklinikum Baden, 2500 Baden, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5544-9540","authenticated-orcid":false,"given":"Claus","family":"Riedl","sequence":"additional","affiliation":[{"name":"Urology Department, Landesklinikum Baden, 2500 Baden, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ghazal","family":"Ameli","sequence":"additional","affiliation":[{"name":"Urology Department, Landesklinikum Korneuburg, 2100 Korneuburg, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9567-0848","authenticated-orcid":false,"given":"Stephan","family":"Doblhammer","sequence":"additional","affiliation":[{"name":"Urology Department, Landesklinikum Korneuburg, 2100 Korneuburg, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harun","family":"Fajkovic","sequence":"additional","affiliation":[{"name":"Division of Urology and Andrology, University Hospital St. P\u00f6lten, 3100 St. P\u00f6lten, Austria"},{"name":"Karl Landsteiner University of Health Sciences, 3500 Krems, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,10,25]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1683","DOI":"10.1016\/S0140-6736(24)00651-2","article-title":"The Lancet Commission on prostate cancer: Planning for the surge in cases","volume":"403","author":"James","year":"2024","journal-title":"Lancet"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1016\/j.eururo.2021.08.005","article-title":"An Updated Systematic Review on Focal Therapy in Localized Prostate Cancer: What Has Changed over the Past 5 Years?","volume":"81","author":"Hopstaken","year":"2022","journal-title":"Eur. 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