Aim: To assess whether artificial intelligence is non-inferior to radiologists in the diagnosis of clinically significant prostate cancer on MRI.
Objectives
Primary
1\. To compare the proportion of men who have clinically significant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy.
Secondary
1. To compare the proportion of men who have clinically insignificant prostate cancer detected on MRI using AI ± targeted biopsy with radiologists ± targeted biopsy.
2. To compare the proportion of men with non-suspicious MRIs for AI vs radiologists.
3. To compare the proportion of men with indeterminately scored MRI as reported by AI vs radiologists.
4. To compare the diagnostic test performance of AI vs radiologist.
5. To compare the additive value of AI when used together with a radiologist interpretation (summative of all identified lesions) compared to a radiologist alone.
6. To compare the additive value of AI when used together with a radiologist interpretation (where the radiologist can interact with the AI system by accepting or rejecting AI-identified lesions) compared to a radiologist alone.
7. To determine the frequency of AI failures.
8. To compare treatment eligibility decisions between AI and Radiologist.
9. To compare the cost-effectiveness of unblinded AI interpreted by the radiologist compared to radiologist alone for prostate cancer detection, and AI alone vs. radiologist alone, and a 3-arm analysis considering all three.
Design:
Prospective, international, within-patient, multi-centre, level-1 evidence trial in participants referred to hospital with a clinical suspicion of prostate cancer.
