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.