Department of Urology and Urologic Oncology, Hanover Medical School, Hanover, Germany.
Institute for Diagnostic and Interventional Radiology, Hanover Medical School, Hanover, Germany.
PLoS One. 2022 Aug 12;17(8):e0271981. doi: 10.1371/journal.pone.0271981. eCollection 2022.
Available tests to detect clinically significant prostate cancer frequently lead to overdiagnosis and overtreatment. Our study assessed the feasibility of combining a urinary biomarker-based risk score (SelectMDx®) and multiparametric MRI outcomes in order to identify patients with prostate cancer on prostate biopsy with increased accuracy and reliability. Samples of 74 men with suspicion of prostate cancer and available multiparametric MRI were analysed in a prospective cross-sectional study design. First-voided urine for determination of HOXC6 and DLX1 mRNA levels was collected after digital rectal examination and prior to MRI/ultrasound fusion-guided prostate biopsy. All multiparametric MRI images were centrally reviewed by two experienced radiologists blinded for urine test results and biopsy outcome. The PI-RADS v2 was used. SelectMDx® score, PI-RADS and Gleason Sore were obtained. Associations between Gleason Score, PI-RADS scores and SelectMDx® were assessed using ANOVA and t-test. Sensitivity and specificity were assessed and evaluated as area-under-the-curve of the receiver operating characteristic. Upon biopsy, 59.5% of patients were diagnosed with prostate cancer, whereby 40.6% had high-grade prostate cancer (GS ≥ 7a). SelectMDx® scores were significantly higher for patients with positive biopsy findings (49.07 ± 25.99% vs. 22.00 ± 26.43%; p < 0.001). SelectMDx® scores increased with higher PI-RADS scores. Combining SelectMDx®, history of prior biopsy with benign histology and PI-RADS scores into a novel scoring system led to significant prostate cancer detection rates with tiered detection rate of 39%, 58%, 81% and 100% for Gleason grade group II, III, IV, and V, respectively. The area-under-the-curve for our novel sum score in receiver operating characteristic analysis was 0.84. The synergistic combination of two non-invasive tests into a sum score with increased sensitivity may help avoiding unnecessary biopsies for initial prostate cancer diagnosis. For confirmation, further prospective studies with larger sample sizes and univariate and multivariate regression analyses and decision curve analyses are required.
现有的用于检测临床显著前列腺癌的检测方法常常导致过度诊断和过度治疗。我们的研究评估了结合基于尿液生物标志物的风险评分（SelectMDx®）和多参数 MRI 结果来识别前列腺活检中前列腺癌患者的可行性，以提高准确性和可靠性。在一项前瞻性横断面研究设计中，分析了 74 名疑似前列腺癌且可获得多参数 MRI 的男性的样本。在 MRI/超声融合引导前列腺活检前，经直肠指检后收集首段尿液以测定 HOXC6 和 DLX1 mRNA 水平。所有多参数 MRI 图像均由两位经验丰富的放射科医生进行中心审查，他们对尿液检测结果和活检结果均不知情。使用 PI-RADS v2。获得 SelectMDx®评分、PI-RADS 和 Gleason 评分。使用 ANOVA 和 t 检验评估 Gleason 评分、PI-RADS 评分与 SelectMDx®之间的相关性。评估了灵敏度和特异性，并作为接收者操作特征曲线的面积进行评估。在活检时，59.5%的患者被诊断为前列腺癌，其中 40.6%为高级别前列腺癌（GS≥7a）。阳性活检结果患者的 SelectMDx®评分明显更高（49.07±25.99%vs.22.00±26.43%；p<0.001）。SelectMDx®评分随 PI-RADS 评分升高而升高。将 SelectMDx®、既往活检史和良性组织学与 PI-RADS 评分组合成一种新的评分系统，显著提高了前列腺癌的检出率，Gleason 分级组 II、III、IV 和 V 的检出率分别为 39%、58%、81%和 100%。在接收器操作特征分析中，我们新的总和评分的曲线下面积为 0.84。两种非侵入性检测方法的协同组合成一个具有更高灵敏度的总和评分可能有助于避免初始前列腺癌诊断的不必要活检。需要进一步进行具有更大样本量的前瞻性研究、单变量和多变量回归分析以及决策曲线分析，以确认结果。
