European Urology

1. Introduction

Prostate cancer is the most common cancer in men in the European Union. It accounted for more than a quarter (27.1%) of all the reported cancer cases in men in the European Union in 2008 [1] x Cancer fact sheets. European Cancer Observatory Web site. http://eu-cancer.iarc.fr/2-cancer-fact-sheets.html,en. Retrieved July 19, 2010. . The estimated incidence of prostate cancer was 110.5 per 100 000, and the mortality rate was 21.1 per 100 000 in 2008. In contrast to the high incidence rate, the mortality rate remains low, reflecting the implementation of population screening measures for prostate cancer on the one hand and the high incidence of localised disease with a favourable prognosis on the other.

The choice of an adequate therapy option for prostate cancer depends on several factors, including tumour stage, prostate-specific antigen (PSA) value, Gleason score, patient's age, concomitant diseases, life expectancy, and patient's preference.

Depending on tumour stage and patient life expectancy, the European Association of Urology (EAU) recommends active surveillance and radical prostatectomy (RP) as standard treatment options for patients with localised prostate cancer [2] x Heidenreich A, Bolla M, Joniau S, et al. Guidelines on prostate cancer. European Association of Urology Web site. http://www.uroweb.org/gls/pdf/Prostate%20Cancer%202010%20June%2017th.pdf. Retrieved July 19, 2010. . Another option for patients with localised prostate cancer or for locally advanced prostate cancer is radiotherapy, particularly in patients who are unfit for surgery or unwilling to undergo surgery. The combination of radiotherapy with hormonal therapy improves overall survival [2] x Heidenreich A, Bolla M, Joniau S, et al. Guidelines on prostate cancer. European Association of Urology Web site. http://www.uroweb.org/gls/pdf/Prostate%20Cancer%202010%20June%2017th.pdf. Retrieved July 19, 2010. .

The American Urological Association (AUA) recommendations encompass active surveillance, interstitial prostate brachytherapy, external-beam radiation therapy (EBRT), and RP for the treatment of patients with low-risk, intermediate-risk as well as high-risk localised prostate cancer [3] x Guideline for the management of clinically localized prostate cancer: 2007 update. American Urological Association Web site. http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm?sub=pc. Retrieved February 10, 2010. . It is acknowledged, based on one randomised controlled trial comparing watchful waiting and RP [4] x A. Bill-Axelson, L. Holmberg, M. Ruutu, M. Haggman, S.O. Andersson, S. Bratell. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med. 2005;352:1977-1984 Crossref. , that RP may be superior to watchful waiting due to a lower risk of cancer recurrence, cancer-related death, and improved survival.

High-intensity focussed ultrasound (HIFU) was developed in the 1990s and is a minimally invasive treatment option for prostate cancer. Ultrasound waves of high intensity are targeted at prostatic tissue via a transrectally inserted ultrasound probe. Due to thermal and mechanical effects, prostatic tissue is destroyed, leading to coagulation necrosis that is replaced by scar tissue within a few weeks following treatment [5] x Home page. EDAP TMS Web site. http://www.edap-tms.com/. Retrieved February 10, 2010. .

Recommendations concerning HIFU in international guidelines are conflicting. Although the medical associations of France [6] x X. Rebillard, M. Soulie, E. Chartier-Kastler, et al. High-intensity focused ultrasound in prostate cancer; a systematic literature review of the French Association of Urology. BJU Int. 2008;101:1205-1213 Crossref. , Italy [7] x Guidelines on prostate cancer: diagnosis, staging and therapy [in Italian]. Associazione Urologi Italiani (Association of Italian Urologists) Web site. http://www.auro.it/index.php/documenti-iniziative/linee-guida/. Retrieved March 25, 2010. , and the United Kingdom [8] x British Uro-oncology Group, British Association of Urological Surgeons, Section of Oncology, British Prostate Group. MDT (multi-disciplinary team) guidance for managing prostate cancer. 2nd edition. British Association of Urological Surgeons Web site. http://www.baus.org.uk/AboutBAUS/publications/mdt-prostate. Updated November 2009. Retrieved March 25, 2010. approve HIFU for the primary and/or salvage treatment of prostate cancer, the EAU [2] x Heidenreich A, Bolla M, Joniau S, et al. Guidelines on prostate cancer. European Association of Urology Web site. http://www.uroweb.org/gls/pdf/Prostate%20Cancer%202010%20June%2017th.pdf. Retrieved July 19, 2010. , the AUA [3] x Guideline for the management of clinically localized prostate cancer: 2007 update. American Urological Association Web site. http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm?sub=pc. Retrieved February 10, 2010. , the National Comprehensive Cancer Network [9] x NCCN clinical practice guidelines in oncology: prostate cancer. v.3. 2010. National Comprehensive Cancer Network Web site. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Retrieved July 19, 2010. , the National Collaborating Centre for Cancer of the National Institute for Health and Clinical Excellence in the United Kingdom [10] x Prostate cancer: diagnosis and treatment. National Collaborating Centre for Cancer for the National Institute for Clinical Excellence Web site. http://guidance.nice.org.uk/CG58. Retrieved February 10, 2010. , and the German Association of Urology (Deutsche Gesellschaft für Urologie) [11] x Deutsche Gesellschaft für Urologie e. V. Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms. http://www.urologenportal.de/fachbesucher.html. Retrieved May 17, 2010. do not recommend the routine use of HIFU in prostate cancer. Disapproval mainly stems from overall lack of data, paucity of evidence concerning improved quality of life and long-term survival, lack of long-term follow-up data, and missing comparisons of HIFU with conventional therapy options. The EAU states that focal therapeutic options such as HIFU are currently not standard therapeutic options for localised prostate cancer and should only be performed within clinical trials, but it emphasises their future potential [2] x Heidenreich A, Bolla M, Joniau S, et al. Guidelines on prostate cancer. European Association of Urology Web site. http://www.uroweb.org/gls/pdf/Prostate%20Cancer%202010%20June%2017th.pdf. Retrieved July 19, 2010. . Since 2010 the EAU has recommended HIFU as an alternative option, in addition to salvage RP, cryosurgery, and interstitial brachytherapy, for the treatment of recurrent prostate cancer following radiotherapy in patients who are well informed about its experimental nature [2] x Heidenreich A, Bolla M, Joniau S, et al. Guidelines on prostate cancer. European Association of Urology Web site. http://www.uroweb.org/gls/pdf/Prostate%20Cancer%202010%20June%2017th.pdf. Retrieved July 19, 2010. .

Two HIFU devices are currently available, the Ablatherm (EDAP TMS SA, Vaulx-en-Velin, France) and the Sonablate device (Focus Surgery Inc, Indianapolis, IN, USA), which have been in use since 1993 and 1995, respectively 5 x Home page. EDAP TMS Web site. http://www.edap-tms.com/. Retrieved February 10, 2010. , and 12 x HIFU – what does the treatment involve? UKHIFU High Intensity Focussed Ultrasound Web site. http://www.ukhifu.co.uk/hifu-treatment.htm. Retrieved May 17, 2010. . Both systems are Conformité Européenne (European Conformity [CE]) marked and are predominantly used in Europe as well as in Japan, whereas in the United States HIFU is still considered experimental and its use is only approved within clinical trials 5 x Home page. EDAP TMS Web site. http://www.edap-tms.com/. Retrieved February 10, 2010. , and 12 x HIFU – what does the treatment involve? UKHIFU High Intensity Focussed Ultrasound Web site. http://www.ukhifu.co.uk/hifu-treatment.htm. Retrieved May 17, 2010. . The differences between Ablatherm and Sonablate treatments mainly concern patient positioning, treatment algorithms, imaging, and technical details. Table 1 provides a detailed comparison of the latest types of the two systems that have been employed in studies published in the literature (Ablatherm Integrated Imaging and Sonablate 500) 5 x Home page. EDAP TMS Web site. http://www.edap-tms.com/. Retrieved February 10, 2010. , 12 x HIFU – what does the treatment involve? UKHIFU High Intensity Focussed Ultrasound Web site. http://www.ukhifu.co.uk/hifu-treatment.htm. Retrieved May 17, 2010. , 13 x R. Illing, M. Emberton, R. Illing, M. Emberton. Sonablate-500: transrectal high-intensity focused ultrasound for the treatment of prostate cancer. Expert Rev Med Devices. 2006;3:717-729 Crossref. , 14 x P. Tsakiris, S. Thüroff, J. de la Rosette, et al. Transrectal high-intensity focused ultrasound devices: a critical appraisal of the available evidence. J Endourol. 2008;22:221-229 , and 15 x R. Illing, A. Chapman, R. Illing, A. Chapman. The clinical applications of high intensity focused ultrasound in the prostate. Int J Hyperthermia. 2007;23:183-191 Crossref. .

The purpose of the present systematic review was to evaluate the evidence on the role of HIFU for the treatment of prostate cancer.