BACKGROUND. On the basis of expert consensus, PI-RADS version 2.1 (v2.1) introduced the transition zone (TZ) atypical benign prostatic hyperplasia (BPH) nodule, defined as a TZ lesion with an incomplete or absent capsule (T2 score, 2). PI-RADS v2.1 also included a revised scoring pathway whereby such nodules, if exhibiting marked restricted diffusion (DWI score, 4-5), are upgraded from overall PI-RADS category 2 to category 3 (2 + 1 TZ lesions). OBJECTIVE. The purpose of this study was to compare the rates of detection of clinically significant prostate cancer (csPCa) in prospectively reported 2 + 1 TZ lesions, as defined by PI-RADS v2.1, and conventional 3 + 0 TZ lesions with targeted biopsy as the reference standard. METHODS. This retrospective study included men with no known PCa or with treatment-naïve grade group (GG) 1 PCa who underwent 3-T multiparametric MRI of the prostate with prospective reporting by means of PI-RADS v2.1. Patients with at least one PI-RADS category 3 TZ lesion who underwent targeted biopsy formed the final sample. Biopsy results were summarized descriptively for 2 + 1 and 3 + 0 lesions. Generalized estimating equations were used to compare csPCa detection rates between groups. Associations between csPCa in 2 + 1 lesions and patient age, PSA level, prostate volume, PSA density, biopsy history, lesion size, and lesion ADC were tested with Kruskal-Wallis and Fisher exact tests. RESULTS. Among 1238 eligible patients who underwent MRI reported with PI-RADS v2.1, 2 + 1 lesions were reported in 6% (n = 69) and 3 + 0 TZ lesions in 7% (n = 87) of patients. No PCa, GG1 PCa, or csPCa was found in 84% (n = 41), 10% (n = 5), and 6% (n = 3) of 49 patients with 2 + 1 lesions who underwent targeted biopsy. Nor were they found in 74% (n = 45), 15% (n = 9), and 11% (n = 7) of 61 patients with 3 + 0 lesions who underwent targeted biopsy. The csPCa detection rate was not significantly different between 2 + 1 and 3 + 0 lesions (p = .31). All cases of csPCa were GG2, except for one 3 + 0 lesion with a GG3 tumor. No clinical or imaging variable was associated with csPCa in 2 + 1 lesions. CONCLUSION. The rate of csPCa in atypical BPH nodules with marked restricted diffusion was low (6%) and not significantly different from that of conventional 3 + 0 TZ lesions (11%). CLINICAL IMPACT. The results provide prospective clinical data about the revised TZ scoring criterion and pathway in PI-RADS v2.1 for atypical BPH nodules with marked restricted diffusion.
Keywords: PI-RADS; biopsy; diagnosis; multiparametric MRI; prostate cancer; structured reporting.