Hendriks Rianne J, van der Leest Marloes M G, Dijkstra Siebren, Barentsz Jelle O, Van Criekinge Wim, Hulsbergen-van de Kaa Christina A, Schalken Jack A, Mulders Peter F A, van Oort Inge M
Department of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Nuclear Medicine and Radiology, Radboud University Medical Center, Nijmegen, The Netherlands.
Prostate. 2017 Oct;77(14):1401-1407. doi: 10.1002/pros.23401. Epub 2017 Aug 29.
Prostate cancer (PCa) diagnostics would greatly benefit from more accurate, non-invasive techniques for the detection of clinically significant disease, leading to a reduction of over-diagnosis and over-treatment. The aim of this study was to determine the association between a novel urinary biomarker-based risk score (SelectMDx), multiparametric MRI (mpMRI) outcomes, and biopsy results for PCa detection.
This retrospective observational study used data from the validation study of the SelectMDx score, in which urine was collected after digital rectal examination from men undergoing prostate biopsies. A subset of these patients also underwent a mpMRI scan of the prostate. The indications for performing mpMRI were based on persistent clinical suspicion of PCa or local staging after PCa was found upon biopsy. All mpMRI images were centrally reviewed in 2016 by an experienced radiologist blinded for the urine test results and biopsy outcome. The PI-RADS version 2 was used.
In total, 172 patients were included for analysis. Hundred (58%) patients had PCa detected upon prostate biopsy, of which 52 (52%) had high-grade disease correlated with a significantly higher SelectMDx score (P < 0.01). The median SelectMDx score was significantly higher in patients with a suspicious significant lesion on mpMRI compared to no suspicion of significant PCa (P < 0.01). For the prediction of mpMRI outcome, the area-under-the-curve of SelectMDx was 0.83 compared to 0.66 for PSA and 0.65 for PCA3. There was a positive association between SelectMDx score and the final PI-RADS grade. There was a statistically significant difference in SelectMDx score between PI-RADS 3 and 4 (P < 0.01) and between PI-RADS 4 and 5 (P < 0.01).
The novel urinary biomarker-based SelectMDx score is a promising tool in PCa detection. This study showed promising results regarding the correlation between the SelectMDx score and mpMRI outcomes, outperforming PCA3. Our results suggest that this risk score could guide clinicians in identifying patients at risk for significant PCa and selecting patients for further radiological diagnostics to reduce unnecessary procedures.
前列腺癌（PCa）诊断将极大地受益于更准确、非侵入性的技术来检测具有临床意义的疾病，从而减少过度诊断和过度治疗。本研究的目的是确定一种基于新型尿液生物标志物的风险评分（SelectMDx）、多参数磁共振成像（mpMRI）结果与PCa检测活检结果之间的关联。
这项回顾性观察研究使用了SelectMDx评分验证研究的数据，其中在接受前列腺活检的男性进行直肠指检后收集尿液。这些患者中的一部分还接受了前列腺的mpMRI扫描。进行mpMRI的指征基于对PCa的持续临床怀疑或活检发现PCa后的局部分期。所有mpMRI图像在2016年由一位经验丰富的放射科医生进行集中审查，该医生对尿液检测结果和活检结果不知情。使用PI-RADS第2版。
总共纳入172例患者进行分析。100例（58%）患者在前列腺活检时检测出PCa，其中52例（52%）患有高级别疾病，其SelectMDx评分显著更高（P < 0.01）。与无明显PCa可疑情况相比，mpMRI上有可疑明显病变的患者的SelectMDx评分中位数显著更高（P < 0.01）。对于mpMRI结果的预测，SelectMDx的曲线下面积为0.83，而前列腺特异性抗原（PSA）为0.66，前列腺癌抗原3（PCA3）为0.65。SelectMDx评分与最终的PI-RADS分级之间存在正相关。PI-RADS 3和4之间（P < 0.01）以及PI-RADS 4和5之间（P < 0.01）的SelectMDx评分存在统计学显著差异。
基于新型尿液生物标志物的SelectMDx评分是PCa检测中有前景的工具。本研究显示了SelectMDx评分与mpMRI结果之间相关性的有前景结果，优于PCA3。我们的结果表明，这种风险评分可以指导临床医生识别有明显PCa风险的患者，并选择患者进行进一步的放射学诊断，以减少不必要的程序。
