Evaluation of PI-RADS version 2.1 vs. 2.0 for detecting clinically significant prostate cancer in biopsy-naïve men.

To evaluate the diagnostic performance of version 2.1 of the prostate imaging reporting and data system (PI-RADS v2.1) compared to version 2.0 (PI-RADS v2.0) for detecting clinically significant prostate cancer (csPCa), we analyzed a cohort using multiparametric MRI (mpMRI). PI-RADS was developed to standardize mpMRI acquisition and interpretation, with version 2.1 introducing revisions to the assessment of transition zone (TZ) lesions aimed at improving detection of prostate cancer (PCa).

We conducted a retrospective study of biopsy-naive men who underwent mpMRI between 2018 and 2022. Patients were grouped by interpretation under PI-RADS v2.0 or v2.1. The primary outcome was detection of csPCa, defined as Grade Group ≥2 on subsequent biopsy. Analyses were performed for the cohort and stratified by the region of the index lesion.

Of 1,427 patients, 1,144 (80.2%) underwent mpMRI evaluated under v2.1 and 283 (19.8%) under v2.0. Compared to v2.0, the v2.1 group had more PI-RADS 5 lesions (21% vs. 16%) and fewer PI-RADS 1 to 2 lesions (8% vs. 14%) (P = 0.004). csPCa detection per patient was higher in the v2.1 group (50% vs. 43%, P = 0.04), driven by improved detection in the TZ (55.1% vs. 39.3%, P = 0.04). No significant difference was seen in the peripheral zone (PZ). Multivariable analysis showed higher csPCa detection for TZ lesions with v2.1 (OR: 1.34, 95% CI: 1.02-1.76, P = 0.03).

PI-RADS v2.1 was associated with csPCa detection in TZ lesions compared to v2.0.

Urologic oncology. 2025 Oct 30 [Epub ahead of print]

Kathryn E Fink, Mitchell M Huang, Eric V Li, Mohammad R Siddiqui, Nicole Handa, Austin Drysch, Ridwan Alam, Anugayathri Jawahar, Edward M Schaeffer, Ashley E Ross, Hiten D Patel

Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, IL. Electronic address: ., Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, IL., Keck Medicine of University of Southern California, Los Angeles, CA., Department of Radiology, Feinberg School of Medicine, Northwestern University, Chicago, IL., Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, IL; Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL., Department of Urology, Feinberg School of Medicine, Northwestern University, Chicago, IL; Surgery Service, Jesse Brown VA Medical Center, Chicago, IL.