High-intensity focused ultrasound for localized prostate cancer: initial experience with a 2-year follow-up.

Objective: To report on the short-term functional and oncological results, from one institution, of high-intensity focused ultrasound (HIFU) for treating localized prostate cancer.

Patients And Methods: Over a 3-year period, 43 patients with localized prostate cancer were scheduled for HIFU in the primary (31) and salvage (12) settings using a second-generation Ablatherm device (EDAP, Lyon, France). Oncological failure was defined by several criteria, including biochemical failure (assessed using both the Phoenix definition of the nadir + 2 ng/mL) and the current Food and Drug Administration (FDA) trial endpoint of a prostate-specific antigen (PSA) level of > or = 0.5 ng/mL, or starting salvage therapy, or the presence of cancer on biopsy after treatment.

Results: Three patients had their procedures abandoned due to technical limitations/rectal wall thickness. The mean PSA levels in the primary and salvage groups were 9.2 and 5.1 ng/mL, respectively. The mean HIFU treatment time in the primary and salvage groups was 71.1 and 63.3 min, respectively. Using the Phoenix definition of biochemical failure, HIFU treatment failed in 13 patients in the primary group (46%) and five in the salvage group. Using the FDA trial endpoint, HIFU failed in 21 patients in the primary group (75%) and eight in the salvage group. One man died from metastatic prostate cancer 18 months after salvage HIFU. There were two urethral strictures in the primary (7%) and one in the salvage treatment group. There were two prostato-rectal fistulae in the salvage HIFU group.

Conclusions: HIFU is proposed to be a minimally invasive low-morbidity ablative treatment for localized prostate cancer, and with good efficacy. The present limited series is unable to support these claims. There were significant rates of complications and oncological failure in both the primary and salvage setting. As a result we have suspended our programme pending further evidence of its safety and efficacy.