From the Departments of Radiology (R.R.) and Urology (P.M.), Hôpital Pitié-Salpétrière, Paris, France; Department of Radiology, Hôpital Cochin, Paris, France (F.C., N.B.); and Departments of Radiology (E.B., D.P.) and Urology (B.M.), Institut Universitaire du Cancer, 1 avenue Irène Joliot Curie, 31059 Toulouse Cedex 9, France.
Radiology. 2015 May;275(2):458-68. doi: 10.1148/radiol.14140184. Epub 2015 Jan 19.
To compare the diagnostic performance of the magnetic resonance (MR) imaging-based Prostate Imaging Reporting and Data System (PI-RADS) and a Likert scale in the detection of prostate cancer in a cohort of patients undergoing initial prostate biopsy.
This institutional review board-approved two-center prospective study included 118 patients with normal digital rectal examination (DRE) results but elevated prostate-specific antigen (PSA) levels (4-20 ng/mL) who were referred for initial prostate biopsies and had one suspicious (Likert scale score, ≥3) focus at prebiopsy 1.5-T multiparametric MR imaging performed with T2-weighted, diffusion-weighted [DW], and dynamic contrast material-enhanced imaging. Targeted core biopsies and random systematic core biopsies were performed. The elementary unit for analysis was the core. Relationships were assessed by using the Mann-Whitney U test. Yates corrected and Pearson χ(2) tests were used to evaluate categoric variables. A training set was randomly drawn to construct the receiver operating characteristic curves for the summed PI-RADS scores and for the Likert scale scores. The thresholds to recommend biopsy were obtained from the Youden J statistics and were tested in the remaining validation set in terms of predictive characteristics. Interobserver variability was analyzed by using weighed κ statistics in a random set of 50 patients.
Higher T2-weighted, DW, and dynamic contrast-enhanced imaging PI-RADS scores were observed in areas that yielded cancer-positive cores. The percentage of positive cores increased with the sum of scores aggregated in five classes as follows: For summed PI-RADS scores of 3-5, the percentage of positive cores was 2.3%; for scores of 6-8, it was 5.8%; for scores of 9 or 10, it was 24.7%; for scores of 11 or 12, it was 51.8%; and for scores of 13-15, it was 72.1% (P for trend, <.0001). For the threshold of summed PI-RADS scores of 9 or greater, sensitivity was 86.6%, specificity was 82.4%, the positive predictive value was 52.4%, the negative predictive value was 96.5%, and accuracy was 83.2%. The respective data for Likert scale scores of 3 or greater were 93.8%, 73.6%, 44.3%, 98.1%, and 73.3%. Good interobserver agreement was observed for the Likert scale (κ = 0.80) and the summed PI-RADS (κ = 0.73) scoring systems.
PI-RADS provided the site-specific stratified risk of cancer-positive cores in biopsy-naive men with normal DRE results and elevated PSA levels. There was no significant difference between summed PI-RADS scores of 9 or greater and Likert scale scores of 3 or greater in the detection of cancer in the peripheral zone.
比较磁共振成像(MR)基于前列腺成像报告和数据系统(PI-RADS)与 Likert 量表在经初次前列腺活检的患者中检测前列腺癌的诊断性能。
本研究经机构审查委员会批准,为前瞻性的双中心研究,共纳入 118 例直肠指诊(DRE)结果正常但前列腺特异性抗原(PSA)水平升高(4-20ng/ml)的患者,这些患者因可疑病灶(Likert 量表评分≥3 分)而行初次前列腺 MR 成像检查,该检查采用了 T2 加权、弥散加权(DW)和动态对比增强成像。行靶向核心活检和随机系统核心活检。分析的基本单位是核心。采用 Mann-Whitney U 检验评估相关性。采用 Yates 校正和 Pearson χ²检验评估分类变量。采用随机抽取的训练集构建 PI-RADS 评分总和和 Likert 评分的受试者工作特征曲线。从 Youden J 统计数据中获得推荐活检的阈值,并在剩余的验证集中测试其预测特征。采用加权 κ 统计数据在 50 例随机患者中分析观察者间的变异性。
在出现癌阳性核心的区域,T2 加权、DW 和动态对比增强成像 PI-RADS 评分较高。阳性核心的百分比随五个等级累加的评分而增加,如下所示:PI-RADS 评分总和为 3-5 时,阳性核心的百分比为 2.3%;评分总和为 6-8 时,为 5.8%;评分总和为 9 或 10 时,为 24.7%;评分总和为 11 或 12 时,为 51.8%;评分总和为 13-15 时,为 72.1%(P<0.0001)。对于 PI-RADS 评分总和≥9 的阈值,灵敏度为 86.6%,特异性为 82.4%,阳性预测值为 52.4%,阴性预测值为 96.5%,准确性为 83.2%。Likert 量表评分≥3 的相应数据为 93.8%、73.6%、44.3%、98.1%和 73.3%。Likert 量表(κ=0.80)和 PI-RADS 评分总和(κ=0.73)评分系统的观察者间一致性较好。
PI-RADS 为直肠指诊结果正常和 PSA 水平升高的初次活检前列腺癌患者提供了基于病灶的前列腺癌阳性核心的分层风险。在外周区,PI-RADS 评分总和≥9 与 Likert 量表评分≥3 在检测癌症方面无显著差异。