Effect of observation size and apparent diffusion coefficient (ADC) value in PI-RADS v2.1 assessment category 4 and 5 observations compared to adverse pathological outcomes.

To compare observation size and apparent diffusion coefficient (ADC) values in Prostate Imaging Reporting and Data System (PI-RADS) v2.1 category 4 and 5 observations to adverse pathological features. With institutional review board approval, 267 consecutive men with 3-T MRI before radical prostatectomy (RP) between 2012 and 2018 were evaluated by two blinded radiologists who assigned PI-RADS v2.1 scores. Discrepancies were resolved by consensus. A third blinded radiologist measured observation size and ADC (ADC.mean, ADC.min [lowest ADC within an observation], ADC.ratio [ADC.mean/ADC.peripheral zone {PZ}]). Size and ADC were compared to pathological stage and Gleason score (GS) using t tests, ANOVA, Pearson correlation, and receiver operating characteristic (ROC) analysis. Consensus review identified 267 true positive category 4 and 5 observations representing 83.1% (222/267) PZ and 16.9% (45/267) transition zone (TZ) tumors. Inter-observer agreement for PI-RADS v2.1 scoring was moderate (K = 0.45). Size was associated with extra-prostatic extension (EPE) (19 ± 8 versus 14 ± 6 mm, p < 0.001) and seminal vesicle invasion (SVI) (24 ± 9 versus 16 ± 7 mm, p < 0.001). Size ≥ 15 mm optimized the accuracy for EPE with area under the ROC curve (AUC) and sensitivity/specificity of 0.68 (CI 0.62–0.75) and 63.2%/65.6%. Size ≥ 19 mm optimized the accuracy for SVI with AUC/sensitivity/specificity of 0.75 (CI 0.66–0.83)/69.4%/70.6%. ADC metrics were not associated with pathological stage. Larger observation size (p = 0.032), lower ADC.min (p = 0.010), and lower ADC.ratio (p = 0.010) were associated with higher GS. Size correlated better to higher Gleason scores (p = 0.002) compared to ADC metrics (p = 0.09–0.11). Among PI-RADS v2.1 category 4 and 5 observations, size was associated with higher pathological stage whereas ADC metrics were not. Size, ADC.minimum, and ADC.ratio differed in tumors stratified by Gleason score. • Among PI-RADS category 4 and 5 observations, size but not ADC can differentiate between tumors by pathological stage. • An observation size threshold of 15 mm and 19 mm optimized the accuracy for diagnosis of extra-prostatic extension and seminal vesicle invasion. • Among PI-RADS category 4 and 5 observations, size, ADC.minimum, and ADC.ratio differed comparing tumors by Gleason score.