NCT05443412 Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection
| NCT ID | NCT05443412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 510 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 510 participants in total. It began in 2023-08-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
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
Contact & Investigator
Peter Ka-Fung CHIU, FRCS, PhD
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT05443412 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05443412 currently recruiting?
Yes, NCT05443412 is actively recruiting participants. Contact the research team at peterchiu@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT05443412 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT05443412 clinical trial?
NCT05443412 is sponsored by Chinese University of Hong Kong. The principal investigator is Peter Ka-Fung CHIU, FRCS, PhD at Chinese University of Hong Kong. The trial plans to enroll 510 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.