Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection
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)
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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) |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | Male |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Chinese University of Hong Kong |
| Locations | Hong Kong, Hong Kong |
| Start date | 2023-08-01 |
| NCT ID | NCT05443412 |
| Official listing | https://clinicaltrials.gov/study/NCT05443412 |