Background Prostate MRI for the detection of clinically significant prostate cancer (csPCa) is standardized by the Prostate Imaging Reporting and Data System (PI-RADS), currently in version 2.1. A systematic review and meta-analysis infrastructure with a 12-month update cycle was established to evaluate the diagnostic performance of PI-RADS over time. Purpose To provide estimates of diagnostic accuracy and cancer detection rates (CDRs) of PI-RADS version 2.1 categories for prostate MRI, which is required for further evidence-based patient management. Materials and Methods A systematic search of PubMed, Embase, Cochrane Library, and multiple trial registers (English-language studies published from March 1, 2019, to August 30, 2022) was performed. Studies that reported data on diagnostic accuracy or CDRs of PI-RADS version 2.1 with csPCa as the primary outcome were included. For the meta-analysis, pooled estimates for sensitivity, specificity, and CDRs were derived from extracted data at the lesion level and patient level. Sensitivity and specificity for PI-RADS greater than or equal to 3 and PI-RADS greater than or equal to 4 considered as test positive were investigated. In addition to individual PI-RADS categories 1-5, subgroup analyses of subcategories (ie, 2+1, 3+0) were performed. Results A total of 70 studies (11 686 lesions, 13 330 patients) were included. At the patient level, with PI-RADS greater than or equal to 3 considered positive, meta-analysis found a 96% summary sensitivity (95% CI: 95, 98) and 43% specificity (95% CI: 33, 54), with an area under the summary receiver operating characteristic (SROC) curve of 0.86 (95% CI: 0.75, 0.93). For PI-RADS greater than or equal to 4, meta-analysis found an 89% sensitivity (95% CI: 85, 92) and 66% specificity (95% CI: 58, 74), with an area under the SROC curve of 0.89 (95% CI: 0.85, 0.92). CDRs were as follows: PI-RADS 1, 6%; PI-RADS 2, 5%; PI-RADS 3, 19%; PI-RADS 4, 54%; and PI-RADS 5, 84%. The CDR was 12% (95% CI: 7, 19) for transition zone 2+1 lesions and 19% (95% CI: 12, 29) for 3+0 lesions (P = .12). Conclusion Estimates of diagnostic accuracy and CDRs for PI-RADS version 2.1 categories are provided for quality benchmarking and to guide further evidence-based patient management. © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Tammisetti and Jacobs in this issue.

中文翻译：

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PI-RADS 2.1 版前列腺 MRI 诊断性能基准更新：系统评价和荟萃分析。


背景 用于检测有临床意义的前列腺癌 (csPCa) 的前列腺 MRI 由前列腺成像报告和数据系统 (PI-RADS) 标准化，目前版本为 2.1。建立了更新周期为 12 个月的系统评价和荟萃分析基础设施，以评估 PI-RADS 随着时间的推移的诊断性能。目的 提供 PI-RADS 2.1 版前列腺 MRI 类别的诊断准确性和癌症检出率 (CDR) 估计，这是进一步循证患者管理所必需的。材料和方法对 PubMed、Embase、Cochrane 图书馆和多个试验注册库（2019 年 3 月 1 日至 2022 年 8 月 30 日发表的英语研究）进行了系统检索。报告了以 csPCa 作为主要结果的 PI-RADS 2.1 版诊断准确性或 CDR 数据的研究也被纳入其中。对于荟萃分析，敏感性、特异性和 CDR 的汇总估计值来自病变水平和患者水平的提取数据。研究了 PI-RADS 大于或等于 3 和 PI-RADS 大于或等于 4 被视为测试阳性的敏感性和特异性。除了单独的 PI-RADS 类别 1-5 之外，还进行了子类别（即 2+1、3+0）的亚组分析。结果共纳入70项研究（11 686个病灶，13 330名患者）。在患者层面，PI-RADS 大于或等于 3 被视为阳性，荟萃分析发现总敏感性为 96% (95% CI: 95, 98)，特异性为 43% (95% CI: 33, 54)，总结受试者工作特征 (SROC) 曲线下面积为 0.86 (95% CI: 0.75, 0.93)。 对于 PI-RADS 大于或等于 4，荟萃分析发现敏感性为 89% (95% CI: 85, 92)，特异性为 66% (95% CI: 58, 74)，SROC 曲线下面积为0.89（95% CI：0.85，0.92）。 CDR如下：PI-RADS 1，6%； PI-RADS 2, 5%; PI-RADS 3，19%； PI-RADS 4，54%；和 PI-RADS 5，84%。过渡区 2+1 病变的 CDR 为 12% (95% CI: 7, 19)，3+0 病变的 CDR 为 19% (95% CI: 12, 29) (P = .12)。结论 PI-RADS 2.1 版类别的诊断准确性和 CDR 估计可用于质量基准测试并指导进一步的循证患者管理。 © RSNA，2024 本文提供补充材料。另请参阅本期 Tammisetti 和 Jacobs 的社论。