The objective of this study was to quantitatively and qualitatively assess the methodologic heterogeneity of the current Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) literature and estimate the proportions of Gleason scores (GSs) diagnosed across PI-RADSv2 categories.

This study was a systematic review and meta-analysis and was performed in concordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Only English-language studies and studies published before April 1, 2018, were assessed. The primary outcome of the meta-analysis was the estimated percentage of patients with GS ≥ 3 + 4 within each individual PI-RADSv2 score. We calculated the pooled estimates and 95% CIs on the basis of a random-effects model using the meta-analysis routine of Stata (version 13.1).

Our search revealed 434 titles, and 59 of these studies were selected. These studies were remarkable for their technical and terminological diverseness. Thirteen studies had sufficient data to be included in the meta-analysis. The prevalence of ≥ GS 3 + 4 in lesions assigned a PI-RADSv2 score of 3 or higher was approximately 45%. Lesions assigned PI-RADSv2 scores 1 or 2, 3, 4, and 5 represented high-grade disease in approximately 6%, 12%, 48%, and 72% of patients.

The data available in the literature are highly heterogeneous and challenging to analyze because of variations in terminology, patient cohort selection, criteria, imaging parameters, and reference standards. In spite of this heterogeneity, our meta-analysis shows that PI-RADSv2 has good sensitivity when a score of ≥ 3 is considered as a positive test.