First Analysis of the Long-Term Results with Transrectal HIFU in Patients with Localised Prostate Cancer

Abstract Objective To evaluate the long-term efficacy of high-intensity focused ultrasound (HIFU) therapy for patients with localised prostate cancer. Material and methods Patients included in this multicentre analysis had T1–T2 NxM0 prostate cancer, a PSA < 15 ng/ml, and a Gleason score (GS) ≤ 7, and were treated with prototypes or first-generation Ablatherm™ HIFU devices between October 1997 and August 2001. The Phoenix definition of biochemical failure was used (PSA nadir + 2). Treatment failure was defined as: biochemical failure or positive biopsy. Results A total of 140 patients with a mean (SD) age 69.1 yr (6.6) were included. Mean (SD) follow-up was 6.4 yr (1.1). Control prostate biopsies were negative in 86.4% of patients. Median PSA nadir of 0.16 ng/ml (range, 0.0–9.1) was achieved at a mean (SD) of 4.9 mo (5.2). A PSA nadir ≤ 0.5 ng/ml was recorded in 68.4% of patients. The actuarial biochemical failure–free survival rates (SR) at 5 and 7 yr were 77% and 69%, respectively. The actuarial disease–free SR at 5 and 7 yr were 66% and 59%, respectively. Conclusions This study demonstrates the effective long-term cancer control achieved with HIFU in patients with low- or intermediate-risk localised prostate cancer.