Diagnostic performance benchmarks of MRI for prostate cancer: a large-scale cohort study of 33,759 patients
Abstract
Objective: To evaluate the real-world diagnostic performance of PI-RADS for detecting clinically significant prostate cancer (csPCa) across large-scale worldwide cohorts.
Materials and methods: This multicenter observational study included 20,429 patients from nine Chinese institutions and a published worldwide meta-analysis dataset comprising 13,330 patients for comparison. All PI-RADS assessments were extracted from original MRI reports produced by clinical radiologists as part of standard diagnostic workflows. Summary receiver operating characteristic curves were constructed using a bivariate random-effects model, and center-level areas under the curve (AUCs) were pooled via random-effects meta-analysis. Subgroup analyses were conducted.
Results: PI-RADS exhibited overall discriminatory performance for csPCa across nine Chinese cohorts comparable to the META results from 70 studies, though significant inter-center variation was observed. Using a PI-RADS ≥ 3 threshold, pooled sensitivity was 92.6% and specificity was 51.5%. At a PI-RADS ≥ 4 threshold, pooled specificity improved to 78.1%, with a sensitivity of 81.5%. The overall diagnostic performance was consistent across thresholds: The summary ROC (SROC) AUC was 0.903 for PI-RADS ≥ 3 and 0.826 for PI-RADS ≥ 4 in detecting csPCa at the meta-analysis level. Subgroup analyses indicated better performance among older patients (≥ 70 years) and those with higher PSA levels (> 20 ng/mL). PI-RADS v2.1 outperformed v2 or earlier versions in most clinical scenarios.
Conclusions: This large-scale real-world study provides critical multicenter evidence supporting the use of PI-RADS in clinical practice worldwide, while also revealing substantial variability in scoring and diagnostic performance across institutions. The findings offer an evidence-based overview of PI-RADS implementation in China and worldwide, highlighting both its utility and inconsistencies.
Key Points: Question What are the real-world PI-RADS diagnostic performance benchmarks for clinically significant prostate cancer detection across diverse Chinese multicenter institutions versus global data?
Findings PI-RADS demonstrated good overall performance (SROC AUC 0.903 at a threshold of ≥ 3), with superior discriminatory ability in older patients, higher PSA levels, and v2.1 users.
Critical relevance statement This article critically assesses substantial inter-institutional heterogeneity in PI-RADS performance, highlighting that pooled estimates should not replace local calibration and that regionally adapted implementation strategies are essential for advancing clinical radiology practice.
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BibTeX
@article{bao2026diagnostic,
title = {{Diagnostic performance benchmarks of MRI for prostate cancer: a large-scale cohort study of 33,759 patients}},
author = {Jie Bao and Mulin Su and Huijuan Tu and Litao Zhao and Yanting Ji and Pengfei Jin and Libiao Ji and Yueting Su and Hailin Shen and Ximing Wang and Xiaoying Wang and Zhen Li and Chunhong Hu and Yudong Zhang},
journal = {Insights into Imaging},
year = {2026},
month = nov,
doi = {10.1186/s13244-026-02460-9},
url = {https://link.springer.com/article/10.1186/s13244-026-02460-9},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Diagnostic performance benchmarks of MRI for prostate cancer: a large-scale cohort study of 33,759 patients
AU - Jie Bao
AU - Mulin Su
AU - Huijuan Tu
AU - Litao Zhao
AU - Yanting Ji
AU - Pengfei Jin
AU - Libiao Ji
AU - Yueting Su
AU - Hailin Shen
AU - Ximing Wang
AU - Xiaoying Wang
AU - Zhen Li
AU - Chunhong Hu
AU - Yudong Zhang
PY - 2026
DA - 2026/11/04
JO - Insights into Imaging
DO - 10.1186/s13244-026-02460-9
UR - https://link.springer.com/article/10.1186/s13244-026-02460-9
AB - Objective: To evaluate the real-world diagnostic performance of PI-RADS for detecting clinically significant prostate cancer (csPCa) across large-scale worldwide cohorts. Materials and methods: This multicenter observational study included 20,429 patients from nine Chinese institutions and a published worldwide meta-analysis dataset comprising 13,330 patients for comparison. All PI-RADS assessments were extracted from original MRI reports produced by clinical radiologists as part of standard diagnostic workflows. Summary receiver operating characteristic curves were constructed using a bivariate random-effects model, and center-level areas under the curve (AUCs) were pooled via random-effects meta-analysis. Subgroup analyses were conducted. Results: PI-RADS exhibited overall discriminatory performance for csPCa across nine Chinese cohorts comparable to the META results from 70 studies, though significant inter-center variation was observed. Using a PI-RADS ≥ 3 threshold, pooled sensitivity was 92.6% and specificity was 51.5%. At a PI-RADS ≥ 4 threshold, pooled specificity improved to 78.1%, with a sensitivity of 81.5%. The overall diagnostic performance was consistent across thresholds: The summary ROC (SROC) AUC was 0.903 for PI-RADS ≥ 3 and 0.826 for PI-RADS ≥ 4 in detecting csPCa at the meta-analysis level. Subgroup analyses indicated better performance among older patients (≥ 70 years) and those with higher PSA levels (> 20 ng/mL). PI-RADS v2.1 outperformed v2 or earlier versions in most clinical scenarios. Conclusions: This large-scale real-world study provides critical multicenter evidence supporting the use of PI-RADS in clinical practice worldwide, while also revealing substantial variability in scoring and diagnostic performance across institutions. The findings offer an evidence-based overview of PI-RADS implementation in China and worldwide, highlighting both its utility and inconsistencies. Key Points: Question What are the real-world PI-RADS diagnostic performance benchmarks for clinically significant prostate cancer detection across diverse Chinese multicenter institutions versus global data? Findings PI-RADS demonstrated good overall performance (SROC AUC 0.903 at a threshold of ≥ 3), with superior discriminatory ability in older patients, higher PSA levels, and v2.1 users. Critical relevance statement This article critically assesses substantial inter-institutional heterogeneity in PI-RADS performance, highlighting that pooled estimates should not replace local calibration and that regionally adapted implementation strategies are essential for advancing clinical radiology practice.
SN - 1869-4101
ER -