Enhanced Detection of Prostate Cancer Lesions on Biparametric MRI Using Artificial Intelligence: A Multicenter, Fully-crossed, Multi-reader Multi-case Trial.

Rationale And Objectives: To assess artificial intelligence (AI)'s added value in detecting prostate cancer lesions on MRI by comparing radiologists' performance with and without AI assistance.

Materials And Methods: A fully-crossed multi-reader multi-case clinical trial was conducted across three institutions with 10 non-expert radiologists. Biparametric MRI cases comprising T2WI, diffusion-weighted images, and apparent diffusion coefficient were retrospectively collected. Three reading modes were evaluated: AI alone, radiologists alone (unaided), and radiologists with AI (aided). Aided and unaided readings were compared using the Dorfman-Berbaum-Metz method. Reference standards were established by senior radiologists based on pathological reports. Performance was quantified via sensitivity, specificity, and area under the alternative free-response receiver operating characteristic curve (AFROC-AUC).

Results: Among 407 eligible male patients (69.5±9.3years), aided reading significantly improved lesion-level sensitivity from 67.3% (95% confidence intervals [CI]: 58.8%, 75.8%) to 85.5% (95% CI: 81.3%, 89.7%), with a substantial difference of 18.2% (95% CI: 10.7%, 25.7%, p<0.001). Case-level specificity increased from 75.9% (95% CI: 68.7%, 83.1%) to 79.5% (95% CI: 74.1%, 84.8%), demonstrating non-inferiority (p<0.001). AFROC-AUC was also higher for aided than unaided reading (86.9% vs 76.1%, p<0.001). AI alone achieved robust performance (AFROC-AUC=83.1%, 95%CI: 79.7%, 86.6%), with lesion-level sensitivity of 88.4% (95% CI: 84.0%, 92.0%) and case-level specificity of 77.8% (95% CI: 71.5%, 83.3%). Subgroup analysis revealed improved detection for lesions with smaller size and lower prostate imaging reporting and data system scores.

Conclusion: AI-aided reading significantly enhances lesion detection compared to unaided reading, while AI alone also demonstrates high diagnostic accuracy.