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High Intensity Focused Ultrasound for the Treatment of Localized Prostate Cancer: Are Its Efficacy and Morbidity Dogmatic? Introduction and Objectives: Transrectal High Intensity Focused Ultrasound (HIFU) as a minimally invasive therapy of localized prostate cancer was evaluated concerning its results and side effects. Materials and Methods: Since 2009, 68 patients with prostate cancer stage T1 and T2 have been treated in our institution with HIFU under general anesthesia using an Ablatherm HIFU device (EDAP SA, Lyon, France). Main patients baseline characteristics were (mean ± SD): age: 74.6 ± 4.6 years, PSA: 7.5 ± 7.8 ng/mL, prostate volume: 19.2 ± 7.4 cc. Gleason scores were 2-4, 5-7 and 8-10 in 8 (11.8%), 58 (85.3%) and 2 (2.9%) patients respectively. During follow-up, prostatic biopsies and PSA level measurements were performed to determine the clinical failure defined as any positive biopsy and the biochemical failure according to the Phoenix ASTRO criteria (PSA + 2 ng/mL). The morbidity was also assessed. Results: The mean patient follow-up was 22.3 ± 11.0 months. The median PSA nadir was 0.15 ng/mL which was reached 12.6 ± 9.3 weeks after HIFU. The 3-year biochemical survival according to the Stuttgart criteria was 82%. Complications occurred mainly in the first weeks after HIFU and with the first patients treated. They included 33 (13.3%) cases of transient pelvic pain, 19 (7.7%) cases of transient mild urinary incontinence, 4 (1.6%) cases of severe urinary incontinence and 8 (3.3%) cases of bladder neck stenosis. Only one case of rectal fistula was seen but no other major complication was noted. Conclusion: HIFU appears to be a promising treatment option for localized prostate cancer with a low morbidity rate. Long term efficacy will be determined by further follow-up.