How does PI-RADS v2.1 impact patient classification? A head-to-head comparison between PI-RADS v2.0 and v2.1

PI-RADS classification has recently been updated, with the magnitude of changes implemented currently unknown.

To quantify the categorization shifts between PI-RADS v2.0 and v2.1.

Retrospective review of 535 consecutive diagnostic magnetic resonance imaging (MRI) studies performed over 18 months, assigning to each case a PI-RADS category in the peripheral zone (PZ), the transition zone (TZ), and the whole gland using both PI-RADS v2.0 and v2.1. Significance of changes in category assignments and of differences in the number of positive or negative MRIs were evaluated using the McNemar test.

Comparing v2.0 to v2.1 for the whole gland, 11.2% of PI-RADS 2 categories shifted to PI-RADS 1 (6.9% in the PZ, 56.8% in the TZ), 16.1% of PI-RADS 3 categories shifted to PI-RADS 2 (15.0% in the PZ, 20.0% in the TZ), and 2.1% of PI-RADS 2 categories shifted to PI-RADS 3 (0.3% in the PZ, 1.9% in the TZ). The proportion of PI-RADS 1 significantly increased from 0.6% to 7.3%, PI-RADS 2 significantly decreased from 60.0% to 53.8%, and PI-RADS 3 non-significantly decreased from 11.6% to 11.0%. The total number of positive exams (PI-RADS 3-5) did not change significantly (39.4% versus 38.8%).

The most prominent change between v2.0 and v2.1 was observed in the TZ with the downgrading of typical benign prostatic hyperplasia nodules from category 2 into category 1. Overall, there were no significant changes in the number of positive and negative MRI results, with an expected low influence in clinical management.