Pavlovich C P, Hyndman M E, Eure G, Ghai S, Caumartin Y, Herget E, Young J D, Wiseman D, Caughlin C, Gray R, Wason S, Mettee L, Lodde M, Toi A, Dujardin T, Lance R, Schatz S M, Fabrizio M, Malcolm J B, Fradet V
The Brady Urological Institute The Johns Hopkins School of Medicine Baltimore MD USA.
Southern Alberta Institute of Urology and Prostate Cancer Centre Calgary AB Canada.
BJUI Compass. 2020 Nov 28;2(2):126-133. doi: 10.1002/bco2.59. eCollection 2021 Mar.
To study high-frequency 29 MHz transrectal side-fire micro-ultrasound (micro-US) for the detection of clinically significant prostate cancer (csPCa) on prostate biopsy, and validate an image interpretation protocol for micro-US imaging of the prostate.
A prospective randomized clinical trial was performed where 1676 men with indications for prostate biopsy and without known prostate cancer were randomized 1:1 to micro-US vs conventional end-fire ultrasound (conv-US) transrectal-guided prostate biopsy across five sites in North America. The trial was split into two phases, before and after training on a micro-US image interpretation protocol that was developed during the trial using data from the pre-training micro-US arm. Investigators received a standardized training program mid-trial, and the post-training micro-US data were used to examine the training effect.
Detection of csPCa (the primary outcome) was no better with the first-generation micro-US system than with conv-US in the overall population (34.6% vs 36.6%, respectively, = .21). Data from the first portion of the trial were, however, used to develop an image interpretation protocol termed PRI-MUS in order to address the lack of understanding of the appearance of cancer under micro-US. Micro-US sensitivity in the post-training group improved to 60.8% from 24.6% (< .01), while specificity decreased (from 84.2% to 63.2%). Detection of csPCa in the micro-US arm increased by 7% after training (32% to 39%, < .03), but training instituted mid-trial did not affect the overall results of the comparison between arms.
Micro-US provided no clear benefit over conv-US for the detection of csPCa at biopsy. However, it became evident during the trial that training and increasing experience with this novel technology improved the performance of this first-generation system.
研究高频29兆赫经直肠侧向发射微超声（微超声）在前列腺活检中检测临床显著前列腺癌（csPCa）的效果，并验证前列腺微超声成像的图像解读方案。
进行了一项前瞻性随机临床试验，1676名有前列腺活检指征且无已知前列腺癌的男性按1:1随机分为微超声组和传统端射超声（传统超声）经直肠引导前列腺活检组，在北美的五个地点进行。该试验分为两个阶段，在使用试验前微超声组数据制定的微超声图像解读方案培训前后。研究人员在试验中期接受了标准化培训方案，培训后的微超声数据用于检验培训效果。
在总体人群中，第一代微超声系统检测csPCa（主要结局）并不比传统超声更好（分别为34.6%和36.6%，P = 0.21）。然而，试验第一部分的数据用于制定一种称为PRI-MUS的图像解读方案，以解决对微超声下癌症表现缺乏了解的问题。培训后组的微超声敏感性从24.6%提高到60.8%（P < 0.01），而特异性降低（从84.2%降至63.2%）。微超声组中csPCa的检测在培训后增加了7%（从32%增至39%，P < 0.03），但试验中期进行的培训并未影响两组间比较的总体结果。
在活检时，微超声在检测csPCa方面相对于传统超声没有明显优势。然而，在试验过程中很明显，对这项新技术的培训和经验增加提高了第一代系统的性能。
