Purpose: Multiparametric MRI (mpMRI) is increasingly used to reduce unnecessary prostate biopsies while maintaining detection of clinically significant prostate cancer (csPCa). False-negative (FN) mpMRI leads to delayed diagnosis. This study aimed to identify clinical and reader associated factors associated with FN mpMRI.
Materials and methods: We retrospectively identified patients who underwent prostate mpMRI followed by prostate biopsy within 1 year. FN cases were compared with true negative (TN) cases in analysis #1 and to true positive cases in analysis #2 using logistic regression and propensity score matching. A sensitivity analysis assessed patients who initially deferred biopsy after negative mpMRI. csPCa was defined as Gleason Grade Group ≥ 2 and positive mpMRI as Prostate Imaging Reporting and Data System ≥ 3.
Results: Six thousand six hundred seventy-nine biopsied patients were identified with 663 TN, 133 FN, and 2993 true positive cases included. Multivariable models predicting csPCa in the negative mpMRI setting found FN cases more frequently had a positive family history, Black race, high PSA density, and more Prostate Imaging Reporting and Data System 2 compared with TN cases. FN mpMRIs were more often read by radiologists without fellowship training (P = .001) and with fewer cumulative annual mpMRI reads (68/y vs 84/y, P < .001). Compared with TP cases, FN cases had lower csPCa volume and grade (Gleason Grade Group: FN 76% vs TP 46). FN cases had more frequent MRI signs of benign prostatic hyperplasia and prostatitis and lower mpMRI radiologist read volume compared with TP cases. Radiologist reads > 50/y was protective against FN mpMRI in both analyses. Of 4069 patients initially deferring biopsy after negative mpMRI, 17% had repeat mpMRI, 12% had biopsy, and 3.4% had csPCa at a median of 2 years.
Conclusions: Clinical predictors of csPCa remain similar among patients with negative mpMRI. MRI benign prostatic hyperplasia and prostatitis along with lower radiologist read volume differentiated FN from TP cases. Enhanced clinical stratification tools and mpMRI refinements could improve confidence in forgoing biopsy for patients with a negative mpMRI.
Keywords: PSAD; false negative; multiparametric MRI; prostate cancer.