PI-RADS Version 2.1 for Prostate MRI Interpretation: Associations of Study Quality and Cancer Detection Metrics-A...

Area of Science:

• Radiology and Imaging
• Urology
• Oncology

Background:

• Estimates for Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v2.1) show heterogeneity, potentially due to bias in studies.
• Prostate cancer diagnosis relies on accurate imaging interpretation.

Purpose of the Study:

• To update diagnostic test accuracy metrics and cancer detection rates (CDRs) for PI-RADS v2.1 in detecting clinically significant prostate cancer (csPCa).
• To analyze how study quality (risk of bias, applicability concerns) affects PI-RADS v2.1 performance estimates.

Main Methods:

• Systematic literature search of seven databases (March 2019-September 2023) for PI-RADS v2.1 diagnostic accuracy and CDR studies.
• Quality assessment using QUADAS-2 tool; meta-analysis using bivariate binomial and logistic regression models.
• Included 117 studies (25,228 patients, 15,553 lesions).

Main Results:

• Overall patient-level sensitivity for PI-RADS ≥3 was 96% (specificity 43%); for PI-RADS ≥4, sensitivity was 88% (specificity 66%).
• Lesion-level sensitivity for PI-RADS ≥4 was lower in high-risk studies (78%) vs. others (89%).
• Patient-level CDRs: PI-RADS 1=3%, 2=6%, 3=20%, 4=53%, 5=83%. CDR for PI-RADS 2 was higher in high-risk studies (15%) vs. others (4%).

Conclusions:

• Updated estimates confirm PI-RADS v2.1's high sensitivity for csPCa detection.
• A significant proportion of studies had quality issues, impacting performance metrics, especially sensitivity and CDR for PI-RADS category 2.
• Study quality is crucial for reliable PI-RADS v2.1 performance evaluation.