Center for Interventional Oncology, NIH Clinical Center, National Institutes of Health, 10 Center Drive, Bethesda, MD, USA.
Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc, NCI Campus at Frederick, 1050 Boyle Street, Frederick, MD, USA.
Abdom Radiol (NY). 2018 Dec;43(12):3436-3444. doi: 10.1007/s00261-018-1631-z.
The purpose of the study was to determine if the ≥ 15 mm threshold currently used to define PIRADS 5 lesions is the optimal size threshold for predicting high likelihood of clinically significant (CS) cancers.
Three hundred and fifty-eight lesions that may be changed from category 4 to 5 or vice versa on the basis of the size criterion (category 4: n = 288, category 5: n = 70) from 255 patients were evaluated. Kendall's tau-b statistic accounting for inter-lesion correlation, generalized estimation equation logistic regression, and receiver operating curve analysis evaluated two lesion size-metrics (lesion diameter and relative lesion diameter-defined as lesion diameter/prostate volume) for ability to identify CS (Gleason grade ≥ 3 + 4) cancer at targeted biopsy. Optimal cut-points were identified using the Youden index. Analyses were performed for the whole prostate (WP) and zone-specific sub-cohorts of lesions in the peripheral and transition zones (PZ and TZ).
Lesion diameter showed a modest correlation with Gleason grade (WP: τB = 0.21, p < 0.0001; PZ: τB = 0.13, p = 0.02; TZ: τB = 0.32, p = 0.001), and association with CS cancer detection (WP: AUC = 0.63, PZ: AUC = 0.59, TZ: AUC = 0.74). Empirically derived thresholds (WP: 14 mm, PZ: 13 mm, TZ: 16 mm) performed similarly to the current ≥ 15 mm standard. Lesion relative lesion diameter improved identification of CS cancers compared to lesion diameter alone (WP: τB = 0.30, PZ: τB = 0.24, TZ: τB = 0.42, all p < 0.0001). AUC also improved for WP and PZ lesions (WP: AUC = 0.70, PZ: AUC = 0.68, and TZ: AUC = 0.74).
The current ≥ 15 mm diameter threshold is a reasonable delineator of PI-RADS category 4 and category 5 lesions in the absence of extraprostatic extension to predict CS cancers. Additionally, relative lesion diameter can improve identification of CS cancers and may serve as another option for distinguishing category 4 and 5 lesions.
本研究旨在确定目前用于定义 PI-RADS5 病变的≥15mm 阈值是否是预测临床显著(CS)癌症的最佳大小阈值。
评估了 255 名患者中可能根据大小标准(类别 4:n=288,类别 5:n=70)从 4 类变为 5 类或反之的 358 个病变。使用 Kendall's tau-b 统计量考虑病变间相关性、广义估计方程逻辑回归和接收者操作曲线分析两种病变大小指标(病变直径和相对病变直径-定义为病变直径/前列腺体积)在靶向活检中识别 CS(Gleason 分级≥3+4)癌症的能力。使用 Youden 指数确定最佳切点。对整个前列腺(WP)和外周和过渡区(PZ 和 TZ)病变的特定区域亚群进行了分析。
病变直径与 Gleason 分级呈中度相关(WP:τB=0.21,p<0.0001;PZ:τB=0.13,p=0.02;TZ:τB=0.32,p=0.001),并与 CS 癌检测相关(WP:AUC=0.63,PZ:AUC=0.59,TZ:AUC=0.74)。经验得出的阈值(WP:14mm,PZ:13mm,TZ:16mm)与当前的≥15mm 标准表现相当。病变相对病变直径与单独病变直径相比,可提高 CS 癌的识别能力(WP:τB=0.30,PZ:τB=0.24,TZ:τB=0.42,均 p<0.0001)。WP 和 PZ 病变的 AUC 也有所提高(WP:AUC=0.70,PZ:AUC=0.68,TZ:AUC=0.74)。
在没有前列腺外延伸的情况下,目前的≥15mm 直径阈值是 PI-RADS 4 类和 5 类病变的合理划定标准,可预测 CS 癌症。此外,相对病变直径可以提高 CS 癌的识别能力,并可能成为区分 4 类和 5 类病变的另一种选择。