High-intensity focused ultrasound (HIFU) using Sonablate{trade mark, serif} devices for the treatment of localized prostate cancer: 13-year experience.

To report on the long-term results of high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer. Eight hundred and eighty-four men with prostate cancer treated with Sonablate® (SB) devices were included. All patients were followed for more than 2 years. The patients were divided into three groups: in the first group, 419 patients were treated with SB200/500 from 1999 to 2006; in the second group, 263 patients were treated with SB 500 ver. 4 from 2005 to 2009: in the third group, 202 patients were treated with SB 500 TCM from 2007 up to present. Biochemical failure was defined according to the Phoenix definition (PSA nadir + 2 ng/ml). The mean age, PSA, Gleason score, operation time, and follow-up period in each group were 68, 66 and 67 years, 11.2, 9.7 and 9.3 ng/ml, 6.2, 6.6 and 6.7, 167, 101 and 106 min, and 56, 48 and 36 months, respectively. The biochemical disease-free rate (bDFR) in each group at 5 years was, respectively, 54%, 61% and 84%, and was 50% at 10 years in the SB200/500 group (p<0.0001). The bDFR in patients in the low-, intermediate-, and high-risk groups in all patients at 10 years were 72% and 58%, 44%, respectively (p<0.0001). The BDFR in patients in the low-, intermediate-, and high-risk groups in the SB500 TCM group at 5 years were 97%, 83%, and 74% (p=0.0056). The negative prostate biopsy rates in 3 groups were 81%, 92% and 88%, respectively. As post HIFU complications, urethral stricture, acute epididymitis and urinary incontinence were noted in 18.0%, 6.2% and 1.9%, respectively. Rectourethral fistula was occurred in 0.6% in the first HIFU cases, Postoperative erectile dysfunction was noted in 27% of patients at 2 years after HIFU. HIFU therapy appears to be minimally invasive, efficacious, and safe for patients with localized prostate cancer. Technological advances as well as cultural and economic vectors have caused a shift from to minimally invasive techniques. [ABSTRACT FROM AUTHOR]