Purpose: To assess the association between the development of a urethral stricture (US) and disease-free survival for patients with localized prostate cancer treated with high-intensity focused ultrasound (HIFU). Patients and Methods: Patients with clinical stage T1-T2N0M0 prostate cancer were eligible for treatment with HIFU. Treatment failure was defined according to the Phoenix criteria, and the disease-free survival rate (DFSR) was evaluated using this definition. Patients were divided into two subgroups according to whether or not they developed a US or a subclinical urethral stricture (SCUS) during follow-up. SCUS was defined as clinically insignificant bladder outlet obstruction requiring transient catheterization. Results: A total of 144 patients were included in the present study. The median follow-up time was 47 months (range 2–70). Grade 1–4 US occurred during follow-up in 28 (19.5%) patients and SCUS was found in 30 (20.8%). The 5-year DFSR by Kaplan-Meier estimation was 61.2% for the entire cohort, 78.2% for patients who developed a US/SCUS and 47.8% for those without US or SCUS (p < 0.001). On Cox regression analysis, development of US/SCUS proved to be an independent predictor of DFSR. Conclusions: Development of US/SCUS was identified as a predictor of favorable HIFU treatment outcome.

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