PURPOSE: To evaluate the association between long-term clinical outcomes and morbidity of high-intensity focused ultrasound (HIFU).
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MATERIALS AND METHODS: We included patients with stage T1c-T3N0M0 prostate cancer who were treated with Sonablate™ (SB) devices during 1999-2012 and followed-up for >2 years. Risk stratification and complication rates were compared between the treatment groups (i.e., SB200/500 group, SB500 version 4 group, and the SB500 tissue change monitor (TCM) group). Primary study outcomes included the overall and cancer-specific survival and biochemical disease-free survival (BDFS) rates, determined using the Kaplan-Meier analysis (Phoenix definition). Secondary outcomes included predictors of BDFS rates using Cox models.
RESULTS: A total of 918 patients were included. The median follow-up periods in the B200/500, SB500 version 4, and the SB500 TCM groups were 108, 83, and 47 months, respectively. The 10-year overall and cancer-specific survival rates were 89.6% and 97.4%, respectively. The 5-year BDFS rates in the SB200/500, SB500 version 4, and SB500 TCM groups were 48.3%, 62.3%, and 82.0%, respectively (p < 0.0001). The overall negative biopsy rate was 87.3%. According to the multivariate analysis, pre-treatment PSA, Gleason score, stage, neoadjuvant androgen deprivation therapy, and HIFU devices were significant predictors of BDFS. Urethral stricture, epididymitis, urinary incontinence, and rectourethral fistula were observed in 19.7%, 6.2%, 2.3% and 0.1% of the cases, respectively.
CONCLUSIONS: Long-term follow-up of patients with HIFU demonstrated improved clinical outcomes owing to technical, imaging, and technological advancements.
Uchida T, Tomonaga T, Kim H, Nakano M, Shoji S, Nagata Y, Terachi T. Are you the author?
Department of Urology, Tokai University Hachioji Hospital, Hachioji, Japan; Department of Urology, Tokai University, Isehara, Japan.
Reference: J Urol. 2014 Jul 28. pii: S0022-5347(14)04047-6.