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

Abstract

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 AblathermTM 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 ≥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.

High-Intensity Focused Ultrasound (HIFU) - An Alternative Choice in Prostate Cancer Treatment

“…Blana et al published a series of 140 men treated with HIFU, reporting good oncological outcome in long-term follow-up (6.4 years), demonstrating the effective long-term cancer control achieved with HIFU in patients with low-or intermediate-risk localised prostate cancer 18 . Finally, it is correct to cite the negative results reported by Challacombe et al, who interrupted the treatment because of the poor oncological outcome 19 . From all the studies presented, there is clear evidence that the treatment could affect prostate cancer, as shown by both a substantial decrease in serum PSA and negative biopsies after therapy there is clear evidence that the treatment could affect prostate cancer.…”

Impact of Ethnicity on Surgical Margins at Radical Prostatectomy

“…Sir, We read your excellent study [1] with interest and have observed similar challenges in our patients with localized prostate cancer. We provide the option of laparoscopic radical prostatectomy (RP) to patients in an ethnically diverse part of south London where African-origin patients make up one third of our cases.…”

“…We commend Challacombe et al [1] for publishing their less than glowing results. While our results mirror some of their experience, we feel the technology continues to advance and cannot be ignored yet.…”

“…Sir, We follow with interest the correspondence following the report by Challacombe et al [1] of their experience of 40 cases of highintensity focused ultrasound (HIFU) at one institution. We agree that it is vital that all data from a new technology are published whether favourable or unfavourable.…”

Transrectal high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer: review of technical incidents and morbidity after 5 years of use

“…Recently, a British team decided to suspend their HIFU treatment programme because of significant rates of oncological failure and complications. 6 The aim of this retrospective study was to review the technical incidents and the complications encountered by a non-investigator centre in the use of the HIFU procedure in the treatment of localized prostate cancer.…”