AI-assisted tests to assess risk of prostate cancer in men
Tests urine, blood, and AI-assisted scans in men at risk of prostate cancer.
Plain-language title generated from the registry record
Registry title: Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection
Key facts
- Where
- Hong Kong, Hong KongSee the site
Where in Hong Kong
- Prince of Wales Hospital, Chinese University of Hong KongHong Kong, Hong KongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chinese University of Hong Kong
- Trial code
- NCT05443412
- Record updated
- 3 November 2026
- Original description
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)Read full original descriptionShow less
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)
Inclusion: 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: Prior prostate biopsy; Past or current history of prostate cancer; 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; Contraindicated to undergo plain MRI scan (e.g. pacemaker in-situ, claustrophobia).