Performance of Artificial Intelligence‐Aided Diagnosis System for Clinically Significant Prostate Cancer with MRI: A Diagnostic Comparison Study.

Background: The high level of expertise required for accurate interpretation of prostate MRI. Purpose: To develop and test an artificial intelligence (AI) system for diagnosis of clinically significant prostate cancer (CsPC) with MRI. Study Type: Retrospective. Subjects: One thousand two hundred thirty patients from derivation cohort between Jan 2012 and Oct 2019, and 169 patients from a publicly available data (U‐Net: 423 for training/validation and 49 for test and TrumpeNet: 820 for training/validation and 579 for test). Field Strength/Sequence: 3.0T/scanners, T2‐weighted imaging (T2WI), diffusion‐weighted imaging, and apparent diffusion coefficient map. Assessment: Close‐loop AI system was trained with an Unet for prostate segmentation and a TrumpetNet for CsPC detection. Performance of AI was tested in 410 internal and 169 external sets against 24 radiologists categorizing into junior, general and subspecialist group. Gleason score >6 was identified as CsPC at pathology. Statistical Tests: Area under the receiver operating characteristic curve (AUC‐ROC); Delong test; Meta‐regression I2 analysis. Results: In average, for internal test, AI had lower AUC‐ROC than subspecialists (0.85 vs. 0.92, P < 0.05), and was comparable to junior (0.84, P = 0.76) and general group (0.86, P = 0.35). For external test, both AI (0.86) and subspecialist (0.86) had higher AUC than junior (0.80, P < 0.05) and general reader (0.83, P < 0.05). In individual, it revealed moderate diagnostic heterogeneity in 24 readers (Mantel–Haenszel I2 = 56.8%, P < 0.01), and AI outperformed 54.2% (13/24) of readers in summary ROC analysis. In multivariate test, Gleason score, zonal location, PI‐RADS score and lesion size significantly impacted the accuracy of AI; while effect of data source, MR device and parameter settings on AI performance is insignificant (P > 0.05). Data Conclusion: Our AI system can match and to some case exceed clinicians for the diagnosis of CsPC with prostate MRI. Evidence Level: 3 Technical Efficacy: Stage 2 [ABSTRACT FROM AUTHOR]