Cutoff Values of Prostate Imaging Reporting and Data System Version 2.1 Score in Men With Prostate-specific Antigen Level 4 to 10 ng/mL: Importance of Lesion Location.

Introduction: Multiparametric magnetic resonance imaging (mpMRI) has been shown to have a good performance in predicting cancer among patients with a prostate-specific antigen (PSA) level of 4 to 10 ng/mL. However, lesion location on mpMRI has never been separately considered.

Patients And Methods: Patients with PSA level of 4 to 10 ng/mL were prospectively enrolled and underwent transrectal ultrasound-guided prostate biopsy. Patient information was collected, and logistic regression analysis was performed to determine the predictive factors of clinically significant prostate cancer (csPCa). Patients were grouped by lesion location to determine the Prostate Imaging Reporting and Data System (PI-RADS) v2.1 cutoff value in predicting csPCa.

Results: Among 222 patients, 121 were diagnosed with PCa and 92 had csPCa. Age, prostate volume, PSA density, location (peripheral zone, csPCa only), and PI-RADS v2.1 score were correlated with PCa and csPCa, and PI-RADS v2.1 score was the best predictor. A PI-RADS v2.1 score of 4 was the best cutoff value for predicting csPCa in patients with lesions only in the transitional zone with respect to the Youden index (0.5896) and negative predictive value (93.10%) with acceptable sensitivity (81.82%) and specificity (77.14%). An adjustment of the cutoff value to 3 for lesions in the peripheral zone would increase the negative predictive value (92.00%) and decrease the false negative rate (2.90%) with an acceptable sensitivity (97.10%) and specificity (30.67%).

Conclusion: PI-RADS v2.1 score is an effective predictor of csPCa in patients with PSA levels of 4 to 10 ng/mL. Patients with transitional zone or peripheral zone lesions should undergo biopsy if the PI-RADS v2.1 score is ≥ 4 or ≥ 3, respectively.