Prostate Cancer Medium-term Outcomes after Whole-gland High-intensity Focused Ultrasound for the Treatment of Nonmetastatic Prostate Cancer from a Multicentre Registry Cohort Louise Dickinson a,b , Manit Arya a,b,c , Naveed Afzal d , Paul Cathcart b , Susan C. Charman e,f , Andrew Cornaby d , Richard G. Hindley g , Henry Lewi h , Neil McCartan a,b , Caroline M. Moore a,b , Senthil Nathan b , Chris Ogden i , Raj Persad j , Jan van der Meulen e , Shraddha Weir b , Mark Emberton a,b,y , Hashim U. Ahmed a,b,y, * a Division of Surgery and Interventional Sciences, University College London, London, UK; b Department of Urology, UCLH NHS Foundation Trust, London, UK; c Department of Urology, Princess Alexandra Hospital NHS Trust, Harlow, UK; d Department of Urology, Dorset County Hospital, Dorchester, UK; e Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK; f Clinical Effectiveness Unit, The Royal College of Surgeons of England, London, UK; g Department of Urology, Basingstoke Hospital, Hampshire Hospitals NHS Foundation Trust, Hampshire, UK; h Department of Urology, Broomfield Hospital, Mid Essex NHS Trust, Chelmsford, UK; i Department of Academic Urology, The Royal Marsden Hospital NHS Foundation Trust, London, UK; j Department of Urology, North Bristol NHS Trust, Bristol, UK E U R O P E A N U R O L O G Y X X X ( 2 0 1 6 ) X X X – X X X ava ilable at www.sciencedirect.com journa l homepage: www.europea nurology.com Article info Article history: Accepted February 18, 2016 Associate Editor: Giacomo Novara Keywords: High-intensity focused ultrasound Abstract Background: High-intensity focused ultrasound (HIFU) is a minimally-invasive treat- ment for nonmetastatic prostate cancer. Objective: To report medium-term outcomes in men receiving primary whole-gland HIFU from a national multi-centre registry cohort. Design, setting, and participants: Five-hundred and sixty-nine patients at eight hospi- tals were entered into an academic registry. Intervention: Whole-gland HIFU (Sonablate 500) for primary nonmetastatic prostate cancer. Redo-HIFU was permitted as part of the intervention. Outcome measurements and statistical analysis: Our primary failure-free survival outcome incorporated no transition to any of the following: (1) local salvage therapy (surgery or radiotherapy), (2) systemic therapy, (3) metastases, or (4) prostate cancer- specific mortality. Secondary outcomes included adverse events and genitourinary function. Results and limitations: Mean age was 65 yr (47–87 yr). Median prostate-specific antigen was 7.0 ng/ml (interquartile range 4.4–10.2). National Comprehensive Cancer Network low-, intermediate-, and high-risk disease was 161 (28%), 321 (56%), and 81 (14%), respectively. One hundred and sixty three of 569 (29%) required a total of 185 redo-HIFU procedures. Median follow-up was 46 (interquartile range 23–61) mo. Failure-free survival at 5 yr after first HIFU was 70% (95% confidence interval [CI]: 64–74). This was 87% (95% CI: 78–93), 63% (95% CI: 56–70), and 58% (95% CI: 32–77) for National Comprehensive Cancer Network low-, intermediate-, and high-risk groups, respectively. Fifty eight of 754 (7.7%) had one urinary tract infection, 22/574 (2.9%) a recurrent urinary tract infection, 22/754 (3%) epididymo-orchitis, 227/754 (30%) y These authors contributed equally. * Corresponding author. Division of Surgery and Interventional Sciences, Rockefeller Building, 21 University Street, University College London, London WC1E 6AU, UK. Tel. +44 (0)20 3447 9194; Fax: +44 (0)20 3447 9303. E-mail address: hashim.ahmed@ucl.ac.uk (H.U. Ahmed). EURURO-6697; No. of Pages 7 Please cite this article in press as: Dickinson L, et al. Medium-term Outcomes after Whole-gland High-intensity Focused Ultrasound for the Treatment of Nonmetastatic Prostate Cancer from a Multicentre Registry Cohort. Eur Urol (2016), http://dx.doi.org/10.1016/j.eururo.2016.02.054 http://dx.doi.org/10.1016/j.eururo.2016.02.054 0302-2838/# 2016 Published by Elsevier B.V. on behalf of European Association of Urology.