Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection
Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection: A Synergy of Novel Biomarkers, Advanced Imaging, and Robotic-assisted Diagnosis
Chinese University of Hong Kong
510 participants
Aug 1, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria4
- 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
Interventions
All recruited patients will undergo investigations including urine for spermine, blood for miRNA, TRUS, and MRI prostate. Patients with high suspicion of Clinically significant prostate cancer in any one step (urine, blood, ultrasound, OR MRI) will be offered an image-guided prostate biopsy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05443412