Introduction

1. No. 023 A Whole-of-Population, Multi-user Series of High-Intensity Focused Ultrasound (HIFU) for Management of Localised Prostate Cancer : Outcomes and Implications K. Ong1, P. Royce2, H. Woo3, G. Giles4, T. Dean3, S. Appu5, A. Troy1, N. Lawrentschuk1, D. Bolton1 1.Department of Surgery/ Urology, University of Melbourne, Austin Health, Victoria 2.Department of Urology, Alfred Health and Cabrini Health, Victoria 3.Department of Urology, Sydney Adventist Hospital, New South Wales 4.Cancer Epidemiology Centre, Cancer Council Victoria 5. Department of Urology, Southern Health, Victoria Introduction Prostate cancer is the most common non-cutaneous cancer in men and the second most common cause of male cancer-related deaths. Although radical prostatectomy remains the standard of care for patients with intermediate or higher grade organ-confined disease and a life expectancy exceeding 10 years, the potential for treatment by focal therapy is being actively evaluated 1-3. High-Intensity Focused Ultrasound (HIFU) utilises the properties of ultrasound which allow it to be brought into tight focus by various means. When the energy density at the focus reaches a sufficient level, tissue damage occurs through coagulative necrosis. There are 2 commercially available transrectal HIFU devices: • Sonablate 500 (Focus Surgery, Indianapolis, USA) • Ablatherm (Edap-Technomed, Lyon, France) Results In all, 108 patients treated with the Sonablate 500 device for primary prostate adenocarcinoma (≤T3bN0M0) were entered into this study. All baseline data is summarised in Table 1. All patients were treated under general anaesthesia in a single session. 102 patients were discharged home the following day. 6 patients were treated as day cases. All patients were risk stratified based on D’Amico classification (1998). In terms of complications, about 12% (N=13) of patients were treated for urinary tract infections in the first 3 months after HIFU.Around 4.6% (N=5) of patients had persistent symptoms of proctitis with one patient subsequently found to have a recto-urethral fistula requiring surgical intervention. Mild stress urinary incontinence (no pads) was reported in 40.5% (N=44) of patients within first 3 months post-HIFU, however 13.9% (N=15) of patients experienced more persistent urinary incontinence (i.e. longer than 6 months). Out of the 15 patients, 9 patients did not require use of pads, 3 patients required use of pads and another 3 patients underwent urological intervention (i.e. collagen injections). Urethral strictures occurred in 6.5% (N=7) of patients where 4 patients were treated with urethrotomy and 3 patients required periodical urethral dilatation. Biochemical outcomes post-HIFU in terms of PSA nadirs are summarised in Table 2. In all, 56 patients underwent post-HIFU prostate biopsies. Positive results were found in 51 patients. As a result, 15 patients were retreated with HIFU, 13 patients underwent salvage radical prostatectomy, 7 patients had salvage external beam radiotherapy, 11 patients were commenced on androgen deprivation therapy and 5 patients were placed on active surveillance. Aim The aim of the study was to systematically review the initial outcomes of men with organ-confined prostate cancer treated with transrectal whole-gland HIFU (Sonablate 500). Methods The study was conducted under the auspices of Cancer Council Victoria, with approval being obtained from ethics committee of this organization for an outcomes database to be established and held for 5 years (2007 – 2011). A group of urologists from Victoria and New South Wales who are HIFU practitioners were approached with their consent to participate in this study. All urologists were blinded to the outcomes of all study patients other than their own patients. All relevant data was collected using CCV-designed data collection forms: Conclusions This study represents the initial learning curve of HIFU performed in Australia. HIFU seems to have offered some promising results for the treatment of localised prostate cancer, especially in cohorts of low and intermediate-risk patients. The progressive refinement of HIFU technology will lead to better clinical safety and outcome. Further prospective randomised-controlled trials compared with other modalities e.g. radical prostatectomy or radiotherapy will further clarify the benefits and role of HIFU as a treatment option. . References HU Ahmed, E Zacharakis, M Emberton et al (2009) High-intensity focused ultrasound in the treatment of primary prostate cancer: the first UK series. British Journal of Cancer (2009) 101, 19 – 26 Blana A, Thuroff S, Gelet A et al (2008) First analysis of the long-term results with transrectal HIFU in patients with localised prostate cancer. EurUrol 53 (6): 1194 – 1201 Blana A, Walter B, Rogenhofer S et al (2004) High-intensity focused ultrasound for the treatment of localised prostate cancer: 5-year experience. Urology 63: 297 – 300 Acknowledgements Many thanks to all participating urologists in this study and their secretaries and Cancer Epidemiology Centre, Cancer Council Victoria. Poster presentation sponsor