Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection
Recruiting
Observational Study
Prostate Cancer
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Study type
Observational
Participants needed
510 (estimated)
Sponsor
Chinese University of Hong Kong · Other
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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)
Trial Locations
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Status
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…
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
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