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)
Conditions: Prostate Cancer
Eligibility Criteria
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
Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.