Assessment of a fully-automated diagnostic AI software in prostate MRI: Clinical evaluation and histopathological correlation

Objective: This study aims to evaluate the diagnostic performance of a commercial, fully-automated, artificial intelligence (AI) driven software tool in identifying and grading prostate lesions in prostate MRI, using histopathological findings as the reference standard, while contextualizing its performance within the framework of PI-RADS v2.1 criteria.

Material and methods: This retrospective study analyzed 123 patients who underwent multiparametric prostate MRI followed by systematic and targeted biopsies. MRI protocols adhered to international guidelines and included T2-weighted, diffusion-weighted, T1-weighted, and dynamic contrast-enhanced imaging. The AI software tool mdprostate was integrated into the Picture Archiving and Communication System to automatically segment the prostate, calculate prostate volume, and classify lesions according to PI-RADS scores using biparametric T2-weighted and diffusion-weighted imaging. Histopathological analysis of biopsy cores served as the reference standard. Diagnostic performance metrics including sensitivity, specificity, positive and negative predictive value (PPV, NPV), and area under the ROC curve (AUC) were calculated.

Results: mdprostate demonstrated 100 % sensitivity at a PI-RADS ≥ 2 cutoff, effectively ruling out both clinically significant and non-significant prostate cancers for lesions remaining below this threshold. For detecting clinically significant prostate cancer (csPCa) using a PI-RADS ≥ 4 cutoff, mdprostate achieved a sensitivity of 85.5 % and a specificity of 63.2 %. The AUC for detecting cancers of any grade was 0.803. The performance metrics of mdprostate were comparable to those reported in two meta-analyses of PI-RADS v2.1, with no significant differences in sensitivity and specificity (p > 0.05).

Conclusion: The evaluated AI tool demonstrated high diagnostic performance in identifying and grading prostate lesions, with results comparable to those reported in meta-analyses of expert readers using PI-RADS v2.1. Its ability to standardize evaluations and potentially reduce variability underscores its potential as a valuable adjunct in the prostate cancer diagnostic pathway. The high accuracy of mdprostate, particularly in ruling out prostate cancers, highlights its clinical utility by reducing workload and enhancing patient outcomes.