Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection

Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection: A Synergy of Novel Biomarkers, Advanced Imaging, and Robotic-assisted Diagnosis

This is a prospective clinical study recruiting 510 men at risk of PCa to undergo urine, blood, AI-assisted ultrasound and AI-assisted MRI investigations to stratify risk of clinically significant PCa (csPCa). (sample size calculation in section 5)

All recruited patients will undergo investigations including urine for spermine, blood for miRNA, TRUS, and MRI prostate. Patients with high suspicion of csPCa in any one step (urine, blood, ultrasound, OR MRI) will be offered an image-guided prostate biopsy. This will be followed by machine learning techniques to find the best combination in predicting csPCa.

Inclusion Criteria:

• Men ≥18 years of age
• Clinical suspicion of prostate cancer
• Serum Prostate-specific antigen (PSA) 4-20 ng/mL
• Digital rectal examination ≤ cT2 (organ confined cancer)
• Able to provide written informed consent

Exclusion Criteria:

• Prior prostate biopsy
• Past or current history of prostate cancer
• Contraindicated to undergo plain MRI scan (e.g. pacemaker in-situ, claustrophobia)
• Contraindicated to transperineal prostate biopsy: active urinary tract infection, fail TRUS probe insertion or lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped