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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Diagnostic test for prostate cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05443412

CRE 2022.245

Details and patient eligibility

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)

Full description

All recruited patients will undergo investigations including urine for spermine, blood for miRNA, TRUS, and MRI prostate. Patients with high suspicion of csPCa in any one step (urine, blood, ultrasound, OR MRI) will be offered an image-guided prostate biopsy. This will be followed by machine learning techniques to find the best combination in predicting csPCa.

Enrollment: 510 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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