A multicenter study of artificial intelligence-aided software for detecting visible clinically significant prostate cancer on mpMRI

Background AI-based software may improve the performance of radiologists when detecting clinically significant prostate cancer (csPCa). This study aims to compare the performance of radiologists in detecting MRI-visible csPCa on MRI with and without AI-based software. Materials and methods In total, 480 multiparametric MRI (mpMRI) images were retrospectively collected from eleven different MR devices, with 349 csPCa lesions in 180 (37.5%) cases. The csPCa areas were annotated based on pathology. Sixteen radiologists from four hospitals participated in reading. Each radiologist was randomly assigned to 30 cases and diagnosed twice. Half cases were interpreted without AI, and the other half were interpreted with AI. After four weeks, the cases were read again in switched mode. The mean diagnostic performance was compared using sensitivity and specificity on lesion level and patient level. The median reading time and diagnostic confidence were assessed. Results On lesion level, AI-aided improved the sensitivity from 40.1% to 59.0% (18.9% increased; 95% confidence interval (CI) [11.5, 26.1]; p <.001). On patient level, AI-aided improved the specificity from 57.7 to 71.7% (14.0% increase, 95% CI [6.4, 21.4]; p <.001) while preserving the sensitivity (88.3% vs. 93.9%, p = 0.06). AI-aided reduced the median reading time of one case by 56.3% from 423 to 185 s (238-s decrease, 95% CI [219, 260]; p <.001), and the median diagnostic confidence score was increased by 10.3% from 3.9 to 4.3 (0.4-score increase, 95% CI [0.3, 0.5]; p <.001). Conclusions AI software improves the performance of radiologists by reducing false positive detection of prostate cancer patients and also improving reading times and diagnostic confidence. Clinical relevance statement This study involves the process of data collection, randomization and crossover reading procedure.