Abstract
CONTEXT: The Prostate Imaging-Reporting and Data System (PI-RADS) v2 analysis system for multiparametric magnetic resonance imaging (mpMRI) detection of prostate cancer (PCa) is based on PI-RADS v1, accumulated scientific evidence, and expert consensus opinion. OBJECTIVE: To summarize the accuracy, strengths and weaknesses of PI-RADS v2, discuss pathway implications of its use and outline opportunities for improvements and future developments. EVIDENCE ACQUISITION: For this consensus expert opinion from the PI-RADS steering committee, clinical studies, systematic reviews, and professional guidelines for mpMRI PCa detection were evaluated. We focused on the performance characteristics of PI-RADS v2, comparing data to systems based on clinicoradiologic Likert scales and non-PI-RADS v2 imaging only. Evidence selections were based on high-quality, prospective, histologically verified data, with minimal patient selection and verifications biases. EVIDENCE SYNTHESIS: It has been shown that the test performance of PI-RADS v2 in research and clinical practice retains higher accuracy over systematic transrectal ultrasound (TRUS) biopsies for PCa diagnosis. PI-RADS v2 fails to detect all cancers but does detect the majority of tumors capable of causing patient harm, which should not be missed. Test performance depends on the definition and prevalence of clinically significant disease. Good performance can be attained in practice when the quality of the diagnostic process can be assured, together with joint working of robustly trained radiologists and urologists, conducting biopsy procedures within multidisciplinary teams. CONCLUSIONS: It has been shown that the test performance of PI-RADS v2 in research and clinical practice is improved, retaining higher accuracy over systematic TRUS biopsies for PCa diagnosis. PATIENT SUMMARY: Multiparametric magnetic resonance imaging (MRI) and MRI-directed biopsies using the Prostate Imaging-Reporting and Data System improves the detection of prostate cancers likely to cause harm, and at the same time decreases the detection of disease that does not lead to harms if left untreated. The keys to success are high-quality imaging, reporting, and biopsies by radiologists and urologists working together in multidisciplinary teams.