Roumiguié Mathieu, Ploussard Guillaume, Nogueira Léonor, Bruguière Eric, Meyrignac Olivier, Lesourd Marine, Péricart Sarah, Malavaud Bernard
Department of Urology, Institut Universitaire du Cancer, 31059 Toulouse, France.
Department of Urology, La Croix du Sud, 31130 Quint Fonsegrives, France.
Cancers (Basel). 2020 Jan 24;12(2):285. doi: 10.3390/cancers12020285.
Upfront MRI is taking the lead in the diagnosis of clinically significant prostate cancer, while few image-guided biopsies (IGBs) fail to demonstrate clinically significant prostate cancer. The added value of innovative biomarkers is not confirmed in this context. We analysed SelectMDx-v2 (MDx-2) in a cohort of upfront MRI and image-guided biopsy patients. Participants included patients who received a trans-rectal elastic-fusion registration IGB on the basis of DRE, PSA, PCA3, and PCPT-2.0 risk evaluation. Pre-biopsy MRI DICOM archives were reviewed according to PI-RADS-v2. Post-massage first-void urine samples stored in the institutional registered bio-repository were commercially addressed to MDxHealth to obtain MDx-2 scores. Univariate and multivariate analyses were conducted with the detection on IGB of high-grade (ISUP 2 and higher) as the dependent variable. High-grade cancer was demonstrated in 32/117 (27.4%) patients (8/2010-8/2018). Age, prostate volume, biopsy history, MDx-2, and PI-RADS-v2 scores significantly related to the detection of high-grade cancer. MDx-2 scores and the clinical variables embedded into MDx-2 scores were analysed in multivariate analysis to complement PI-RADS-v2 scores. The two combinations outperformed PI-RADS-v2 alone (AUC-ROC 0.67 vs. 0.73 and 0.80, respectively, < 0.05) and calibration curves confirmed an adequate prediction. Similar discrimination (C-statistics, = 0.22) was observed in the prediction of high-grade cancer, thereby questioning the respective inputs and added values of biomarkers and clinical predictors in MDx-2 scores. Based on the results of this study, we can conclude that instruments of prediction developed for systematic prostate biopsies, including those that incorporate innovative biomarkers, must be reassessed and eventually confirmed in the context of upfront MRI and IGB.
初诊MRI在临床显著性前列腺癌的诊断中占据主导地位，而很少有影像引导活检（IGB）未能发现临床显著性前列腺癌。在这种情况下，创新生物标志物的附加价值尚未得到证实。我们在一组初诊MRI和影像引导活检患者中分析了SelectMDx-v2（MDx-2）。参与者包括那些基于直肠指检（DRE）、前列腺特异性抗原（PSA）、前列腺癌抗原3（PCA3）和PCPT-2.0风险评估接受经直肠弹性融合配准IGB的患者。根据前列腺影像报告和数据系统（PI-RADS）v2对活检前MRI的DICOM存档进行评估。存储在机构注册生物样本库中的按摩后首次排尿尿液样本被送往MDxHealth进行商业检测，以获得MDx-2评分。以IGB检测到高级别（国际泌尿病理学会[ISUP] 2级及以上）癌症为因变量进行单因素和多因素分析。在32/117（27.4%）例患者（2010年8月至2018年8月）中发现了高级别癌症。年龄、前列腺体积、活检史、MDx-2和PI-RADS v2评分与高级别癌症的检测显著相关。在多因素分析中对MDx-2评分以及MDx-2评分中包含的临床变量进行分析，以补充PI-RADS v2评分。这两种组合的表现均优于单独的PI-RADS v2（受试者工作特征曲线下面积[AUC-ROC]分别为0.67对0.73和0.80，P<0.05），校准曲线证实了充分的预测效果。在高级别癌症的预测中观察到类似的鉴别能力（C统计量，P = 0.22），从而对MDx-2评分中生物标志物和临床预测指标的各自输入值和附加价值提出质疑。基于本研究结果，我们可以得出结论，为系统性前列腺活检开发的预测工具，包括那些纳入创新生物标志物的工具，必须在初诊MRI和IGB的背景下重新评估并最终得到确认。
