CONTEXT: High-intensity focussed ultrasound (HIFU) has been used for 10 yr to treat localised prostate cancer (PCa).
OBJECTIVE: To evaluate systematically the evidence on the efficacy and side effects of HIFU in the primary treatment of localised PCa.
EVIDENCE ACQUISITION: We performed a critical review and appraisal of Medline (Ovid), PreMedline, Embase, and Cochrane Database of Systematic Reviews publications on HIFU up to May 2013. One systematic review and 18 primary studies, all case series, were eligible.
EVIDENCE SYNTHESIS: Outcomes were summarised and evidence was evaluated using Grading of Recommendations, Assessment, Development and Evaluation methodology. Low-quality evidence suggests an overall survival rate after Ablatherm HIFU ranging from 80% to 89% for >5 yr. The PCa survival rate ranges from 97% to 99% for >5 yr. Effect of HIFU on quality of life remains undetermined. Erectile dysfunction was the most frequent adverse event reported from zero but up to 74% of patients. Adverse events affecting the urinary tract occurred in 0.7-31% of patients, bladder outlet obstruction in 4-51.5%, and they were more frequent in patients who had transurethral resection of the prostate the same day or within 2 d of HIFU. Outcomes vary for low- and high-risk categories.
CONCLUSIONS: Good quality evidence on the efficacy of HIFU treatment for localised PCa is lacking.
PATIENT SUMMARY: We reviewed all the data on treatment with high-intensity focussed ultrasound (HIFU) for localised prostate cancer (PCa). The quality of the evidence is very low because the information is based on a series of patients who received HIFU treatment with no comparison with active surveillance or radical treatment. Case series suggest an overall survival rate up to 89% and a PCa survival rate up to 99% after 5 yr, but these numbers vary according to the patient's risk category. Longer term and effects on quality of life are unknown.