Medium-term Outcomes after Whole-gland High-intensity Focused Ultrasound for the Treatment of Nonmetastatic Prostate Cancer from a Multicentre Registry Cohort



      High-intensity focused ultrasound (HIFU) is a minimally-invasive treatment for nonmetastatic prostate cancer.


      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 hospitals were entered into an academic registry.


      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%) endoscopic interventions, 1/754 (0.13%) recto-urethral fistula, and 1/754 (0.13%) osteitis pubis. Of 206 known to be pad-free pre-HIFU, 183/206 (88%) remained pad free, and of 236 with good baseline erectile function, 91/236 (39%) maintained good function. The main limitation is lack of long-term data.


      Whole-gland HIFU is a repeatable day-case treatment that confers low rates of urinary incontinence. Disease control at a median of just under 5 yr of follow-up demonstrates its potential as a treatment for nonmetastatic prostate cancer. Endoscopic interventions and erectile dysfunction rates are similar to other whole-gland treatments.

      Patient summary

      In this report we looked at the 5-yr outcomes following whole-gland high-intensity focused ultrasound treatment for prostate cancer and found that cancer control was acceptable with a low risk of urine leakage. However, risk of erectile dysfunction and further operations was similar to other whole-gland treatments like surgery and radiotherapy.


      To read this article in full you will need to make a payment


      Subscribe to European Urology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Wilt T.J.
        • Ahmed H.U.
        Prostate cancer screening and the management of clinically localized disease.
        BMJ. 2013; 346: f325
        • Hu J.C.
        • Gu X.
        • Lipsitz S.R.
        • et al.
        Comparative effectiveness of minimally invasive vs open radical prostatectomy.
        JAMA. 2009; 302: 1557-1564
        • Kommu S.S.
        • Eden C.G.
        • Luscombe C.J.
        • Golash A.
        • Persad R.A.
        Initial treatment costs of organ-confined prostate cancer: a general perspective.
        BJU Int. 2011; 107: 1-3
        • Nguyen P.L.
        • Gu X.
        • Lipsitz S.R.
        • et al.
        Cost implications of the rapid adoption of newer technologies for treating prostate cancer.
        J Clin Oncol. 2011; 29: 1517-1524
        • Ahmed H.U.
        • Zacharakis E.
        • Dudderidge T.
        • et al.
        High-intensity focused ultrasound in the treatment of primary prostate cancer: the first UK series.
        Br J Cancer. 2009; 101: 19-26
        • Warmuth M.
        • Johansson T.
        • Mad P.
        Systematic review of the efficacy and safety of high-intensity focused ultrasound for the primary and salvage treatment of prostate cancer.
        Eur Urol. 2010; 58: 803-815
        • Craig P.
        • Dieppe P.
        • Macintyre S.
        • et al.
        Developing and evaluating complex interventions: the new Medical Research Council guidance.
        BMJ. 2008; 337: a1655
        • Ergina P.L.
        • Barkun J.S.
        • McCulloch P.
        • Cook J.A.
        • Altman D.G.
        • IDEAL Group
        IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages.
        BMJ. 2013; 346: f3011
        • Punwani S.
        • Emberton M.
        • Walkden M.
        • et al.
        Prostatic cancer surveillance following whole-gland high-intensity focused ultrasound: comparison of MRI and prostate-specific antigen for detection of residual or recurrent disease.
        Br J Radiol. 2012; 85: 720-728
        • Ahmed H.U.
        • Hu Y.
        • Carter T.
        • et al.
        Characterizing clinically significant prostate cancer using template prostate mapping biopsy.
        J Urol. 2011; 186: 458-464
        • Roach 3rd, M.
        • Hanks G.
        • Thames Jr., H.
        • et al.
        Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference.
        Int J Radiat Oncol Biol Phys. 2006; 65: 965-974
        • Blana A.
        • Brown S.C.
        • Chaussy C.
        • Conti G.N.
        • Eastham J.A.
        • Ganzer R.
        High-intensity focused ultrasound for prostate cancer: comparative definitions of biochemical failure.
        BJU Int. 2009; 104: 1058-1062
        • Rosen R.C.
        • Riley A.
        • Wagner G.
        • Osterloh I.H.
        • Kirkpatrick J.
        • Mishra A.
        The international index of erectile function (IIEF): a multi-dimensional scale for assessment of erectile dysfunction.
        Urology. 1997; 49: 822-830
        • Litwin M.S.
        • Hays R.D.
        • Fink A.
        • Ganz P.A.
        • Leake B.
        • Brook R.H.
        The UCLA Prostate Cancer Index: development, reliability, and validity of a health-related quality of life measure.
        Med Care. 1998; 36: 1002-1012
        • Uchida T.
        • Tomonaga T.
        • Kim H.
        • et al.
        Improved outcomes with advancements in high intensity focused ultrasound devices for the treatment of localized prostate cancer.
        J Urol. 2015; 193: 103-110
        • Crouzet S.
        • Chapelon J.Y.
        • Rouvière O.
        • et al.
        Whole-gland ablation of localized prostate cancer with high-intensity focused ultrasound: oncologic outcomes and morbidity in 1002 patients.
        Eur Urol. 2014; 65: 907-914
        • Ganzer R.
        • Fritsche H.M.
        • Brandtner A.
        • et al.
        Fourteen-year oncological and functional outcomes of high-intensity focused ultrasound in localized prostate cancer.
        BJU Int. 2013; 112: 322-329
        • Bolton D.
        • Ong K.
        • Giles G.
        • et al.
        A whole of population, multi-user series of hifu for management of localised prostate cancer: outcomes and implications.
        J Endourol. 2015; 29: 844-849
        • Challacombe B.J.
        • Murphy D.G.
        • Zakri R.
        • Cahill D.J.
        High-intensity focused ultrasound for localized prostate cancer: initial experience with a 2-year follow-up.
        BJU Int. 2009; 104: 200-204
        • Nam R.K.
        • Cheung P.
        • Herschorn S.
        • et al.
        Incidence of complications other than urinary incontinence or erectile dysfunction after radical prostatectomy or radiotherapy for prostate cancer: a population-based cohort study.
        Lancet Oncol. 2014; 15: 223-231
        • Resnick M.J.
        • Koyama T.
        • Fan K.H.
        • et al.
        Long-term functional outcomes after treatment for localized prostate cancer.
        N Engl J Med. 2013; 368: 436-445
        • Cathcart P.
        • Sridhara A.
        • Ramachandran N.
        • Briggs T.
        • Nathan S.
        • Kelly J.
        Achieving quality assurance of prostate cancer surgery during reorganisation of cancer services.
        Eur Urol. 2015; 68: 22-29
        • Alemozaffar M.
        • Regan M.M.
        • Cooperberg M.R.
        • et al.
        Prediction of erectile function following treatment for prostate cancer.
        JAMA. 2011; 306: 1205-1214
        • Ahmed H.U.
        • Pendse D.
        • Illing R.
        • Allen C.
        • van der Meulen J.H.
        • Emberton M.
        Will focal therapy become a standard of care for men with localised prostate cancer?.
        Nat Clin Pract Oncol. 2007; 4: 632-642
        • De la Rosette J.
        • Ahmed H.U.
        • Barentsz J.
        • et al.
        Focal therapy in prostate cancer – report from a consensus panel.
        J Endourol. 2010; 24: 775-780
        • Langley S.
        • Ahmed H.U.
        • Al-Qaisieh B.
        • et al.
        Report of a consensus meeting on focal low dose rate brachytherapy for prostate cancer.
        BJU Int. 2012; 109: 7-16
        • Ahmed H.U.
        • Freeman A.
        • Kirkham A.
        • et al.
        Focal therapy for localized prostate cancer: a phase I/II trial.
        J Urol. 2011; 185: 1246-1254
        • Ahmed H.U.
        • Dickinson L.
        • Charman S.
        • et al.
        Focal ablation targeted to the index lesion in multifocal localised prostate cancer: a prospective development study.
        Eur Urol. 2015; 68: 927-936
        • Ahmed H.U.
        • Hindley R.G.
        • Dickinson L.
        • et al.
        Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study.
        Lancet Oncol. 2012; 13: 622-632
        • Dickinson L.
        • Ahmed H.U.
        • Kirkham A.P.
        • et al.
        A multi-centre prospective development study evaluating focal therapy using high intensity focused ultrasound for localised prostate cancer: The INDEX study.
        Contemp Clin Trials. 2013; 36: 68-80
        • Berge V.
        • Dickinson L.
        • McCartan N.
        • et al.
        Morbidity associated with primary high intensity focused ultrasound and redo high intensity focused ultrasound for localised prostate cancer.
        J Urol. 2014; 191: 1764-1769