Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection
Recruiting · NCT05443412 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
Diagnostic test for prostate cancer
What this trial is about
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 take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Prince of Wales Hospital, Chinese University of Hong Kong - Hong Kong, Hong Kong