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Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection

RECRUITINGSponsored by Chinese University of Hong Kong
Actively Recruiting
SponsorChinese University of Hong Kong
Started2023-08-01
Est. completion2026-07-31
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05443412

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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