Clinical results of the prostate HIFU project

Objectives: To demonstrate that the "High Intensity Focused Ultrasound" (HIFU) technique can compete with surgery and radiation therapy to cure patients with localized Prostate Cancer (PCa). Methods: The authors report on the HIFU results obtained in Europe using the Ablatherm device and mainly on the Lyon experience involving 242 patients followed up to five years. Mean age at inclusion was 71 +/- 5.5 yr, mean PSA was 9.22 ng/ml and 51.2% of the patients had T2 disease. The main response criteria were to obtain negative prostate biopsy at 3 months and PSA less than 1 ng/ml and stable. Results: 86% of patients had negative biopsies at 3 months with a median PSA nadir of 0.1 ng/ml. The success rate at 3 months as defined above was 82%. The disease free survival rate was 65% from 10 months to 5 years. Response and disease free survival rates were dependent on preoperative prognosis features defined in D'Amico's classification. The most reported adverse event was postoperative sloughing of necrotic tissue (4%) and pelvic perineal pain (1-2%). The rate of postHIFU impotence was roughly 70%. Furthermore, bladder neck stenosis occured in 12 to 16% and grade 1 urinary incontinence from 5.8 to 9.5%. Conclusions: HIFU is a valid option to treat patients with low risk localized prostate cancer especially in old patients, with an acceptable morbidity. It is also used as a salvage therapy for local recurrence after external beam radiation therapy. (c) 2006 Published by Elsevier B.V.