Challacombe Benjamin J, Murphy Declan G, Zakri Rhana, Cahill Declan J
The Urology Centre, Guy's and St Thomas' NHS Foundation Trust, London, UK.
BJU Int. 2009 Jul;104(2):200-4. doi: 10.1111/j.1464-410X.2009.08355.x. Epub 2009 Feb 11.
To report on the short-term functional and oncological results, from one institution, of high-intensity focused ultrasound (HIFU) for treating localized prostate cancer.
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.
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.
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.
报告一家机构使用高强度聚焦超声（HIFU）治疗局限性前列腺癌的短期功能和肿瘤学结果。
在3年期间，43例局限性前列腺癌患者计划使用第二代Ablatherm设备（法国里昂的EDAP公司）在初始（31例）和挽救性（12例）治疗中接受HIFU治疗。肿瘤学失败由多种标准定义，包括生化失败（使用最低点加2 ng/mL的Phoenix定义进行评估）以及当前美国食品药品监督管理局（FDA）试验终点——前列腺特异性抗原（PSA）水平≥0.5 ng/mL，或开始挽救性治疗，或治疗后活检发现癌症。
3例患者因技术限制/直肠壁厚度而放弃手术。初始组和挽救性治疗组的平均PSA水平分别为9.2 ng/mL和5.1 ng/mL。初始组和挽救性治疗组的平均HIFU治疗时间分别为71.1分钟和63.3分钟。根据生化失败的Phoenix定义，初始组有13例患者（46%）HIFU治疗失败，挽救性治疗组有5例。根据FDA试验终点，初始组有21例患者（75%）HIFU治疗失败，挽救性治疗组有8例。1例男性在挽救性HIFU治疗18个月后死于转移性前列腺癌。初始组有2例尿道狭窄（7%），挽救性治疗组有1例。挽救性HIFU治疗组有2例前列腺直肠瘘。
HIFU被认为是一种治疗局限性前列腺癌的微创、低发病率的消融治疗方法，且疗效良好。目前有限的病例系列无法支持这些说法。在初始和挽救性治疗中，并发症和肿瘤学失败的发生率都很高。因此，我们已暂停该项目，等待其安全性和有效性的进一步证据。
