Artificial Intelligence and Radiologists at Prostate Cancer Detection in MRI: The PI-CAI Challenge (Study Protocol)

Abstract

This document represents the preregistration of <strong>the PI-CAI challenge</strong> study design, in compliance with <strong>MICCAI-BIAS reporting guidelines</strong>. The PI-CAI challenge is an all-new grand challenge that aims to validate the diagnostic performance of artificial intelligence and radiologists at clinically significant prostate cancer (csPCa) detection/diagnosis in MRI, with histopathology and follow-up (≥ 3 years) as the reference standard, in a retrospective setting. The study hypothesizes that state-of-the-art AI algorithms, trained using thousands of patient exams, are non-inferior to radiologists reading bpMRI. Key aspects of the PI-CAI study design have been established in conjunction with an international scientific advisory board of 16 experts in prostate AI, radiology and urology —to unify and standardize present-day guidelines, and to ensure meaningful validation of prostate AI towards clinical translation (<strong>Reinke et al., 2021</strong>).

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