Klotz Laurence, Lughezzani Giovanni, Maffei Davide, Sánchez Andrea, Pereira José Gregorio, Staerman Frédéric, Cash Hannes, Luger Ferdinand, Lopez Laurent, Sanchez-Salas Rafael, Abouassaly Rob, Shore Neal D, Eure Gregg, Paciotti Marco, Astobieta Ander, Wiemer Laura, Hofbauer Sebastian, Heckmann Robin, Gusenleitner Andreas, Kaar Jasmin, Mayr Clemens, Loidl Wolfgang, Rouffilange Jean, Gaston Richard, Cathelineau Xavier, Klein Eric
Sunnybrook Hospital, Toronto, ON, Canada.
Instituto Clinico Humanitas, Rozzano, Italy.
Can Urol Assoc J. 2021 Jan;15(1):E11-E16. doi: 10.5489/cuaj.6712.
High-resolution micro-ultrasound has the capability of imaging prostate cancer based on detecting alterations in ductal anatomy, analogous to multiparametric magnetic resonance imaging (mpMRI). This technology has the potential advantages of relatively low cost, simplicity, and accessibility compared to mpMRI. This multicenter, prospective registry aims to compare the sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV) of mpMRI with high-resolution micro-ultrasound imaging for the detection of clinically significant prostate cancer.
We included 1040 subjects at 11 sites in seven countries who had prior mpMRI and underwent ExactVu micro-ultrasound-guided biopsy. Biopsies were taken from both mpMRI targets (Prostate Imaging-Reporting and Data System [PI-RADS] >3 and micro-ultrasound targets (Prostate Risk Identification using Micro-ultrasound [PRIMUS] >3). Systematic biopsies (up to 14 cores) were also performed. Various strategies were used for mpMRI target sampling, including cognitive fusion with micro-ultrasound, separate software-fusion systems, and software-fusion using the micro-ultrasound FusionVu system. Clinically significant cancer was those with Gleason grade group ≥2.
Overall, 39.5% were positive for clinically significant prostate cancer. Micro-ultrasound and mpMRI sensitivity was 94% vs. 90%, respectively (p=0.03), and NPV was 85% vs. 77%, respectively. Specificities of micro-ultrasound and MRI were both 22%, with similar PPV (44% vs. 43%). This represents the initial experience with the technology at most of the participating sites and, therefore, incorporates a learning curve. Number of cores, diagnostic strategy, blinding to MRI results, and experience varied between sites.
In this initial multicenter registry, micro-ultrasound had comparable or higher sensitivity for clinically significant prostate cancer compared to mpMRI, with similar specificity. Micro-ultrasound is a low-cost, single-session option for prostate screening and targeted biopsy. Further larger-scale studies are required for validation of these findings.
高分辨率微型超声能够基于检测导管解剖结构的改变对前列腺癌进行成像，这类似于多参数磁共振成像（mpMRI）。与mpMRI相比，这项技术具有成本相对较低、操作简单且易于获得的潜在优势。这项多中心前瞻性登记研究旨在比较mpMRI与高分辨率微型超声成像在检测临床显著性前列腺癌方面的敏感性、特异性、阴性预测值（NPV）和阳性预测值（PPV）。
我们纳入了来自七个国家11个地点的1040名受试者，这些受试者之前接受过mpMRI检查，并接受了ExactVu微型超声引导下的活检。活检取自mpMRI目标（前列腺影像报告和数据系统[PI-RADS]＞3）和微型超声目标（使用微型超声进行前列腺风险识别[PRIMUS]＞3）。还进行了系统活检（最多14针）。mpMRI目标采样采用了多种策略，包括与微型超声的认知融合、单独的软件融合系统以及使用微型超声FusionVu系统的软件融合。临床显著性癌症是指Gleason分级组≥2的癌症。
总体而言，39.5%的患者临床显著性前列腺癌呈阳性。微型超声和mpMRI的敏感性分别为94%和90%（p = 0.03），NPV分别为85%和77%。微型超声和MRI的特异性均为22%，阳性预测值相似（44%对43%）。这代表了大多数参与地点对该技术的初步经验，因此包含了一个学习曲线。各地点之间的活检针数、诊断策略、对MRI结果的盲法以及经验各不相同。
在这项初步的多中心登记研究中，与mpMRI相比，微型超声对临床显著性前列腺癌具有相当或更高的敏感性，特异性相似。微型超声是一种用于前列腺筛查和靶向活检的低成本、单次检查的选择。需要进一步开展更大规模的研究来验证这些发现。
