Context: High-intensity focussed ultrasound (HIFU) is an emerging minimally invasive treatment option for prostate cancer. Objective: Our aim was to assess the efficacy and safety of HIFU in both primary treatment of men with localised and locally advanced prostate cancer as well as salvage treatment of men with recurrent prostate cancer following treatment failure of radical prostatectomy or external-beam radiation therapy. Evidence acquisition: We conducted a systematic literature search for studies conducted on humans and published in either English or German in several databases from 2000 to 2010. In addition, we screened several Web sites for assessments on HIFU in prostate cancer and contacted the manufacturers of the two currently available HIFU devices for supplemental information on HIFU. We included all prospective studies with > 50 study participants and assessed their quality using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Evidence synthesis: We identified 20 uncontrolled prospective case series, each of which treated between 58 and 517 patients. These studies were all conducted within the past decade. In total, 3018 patients were treated with HIFU, 93% for primary therapy and 7% for salvage HIFU. For all HIFU procedures, the biochemical disease-free survival rate at 1, 5, and 7 yr, respectively, was 78-84%, 45-84%, and 69%. The negative biopsy rate was 86% at 3 mo and 80% at 15 mo. Overall survival rates and prostate cancer-specific survival rates were 90% and 100% at 5 yr and 83% and 98% at 8 yr, respectively. Adverse events concerned the urinary tract (1-58%), potency (1-77%), the rectum (0-15%), and pain (1-6%). Quality-of-life assessment yielded controversial results. Conclusions: Applying the GRADE approach, the available evidence on efficacy and safety of HIFU in prostate cancer is of very low quality, mainly due to study designs that lack control groups. More research is needed to explore the use of HIFU in prostate cancer. (C) 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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