AI-assisted detection of prostate cancer risk
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 · NCT05443412
This study is testing if using AI with different tests can help find out which men are at higher risk for serious prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 510 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05443412 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit 510 men at risk of prostate cancer to undergo a series of diagnostic tests, including urine and blood tests, as well as AI-assisted ultrasound and MRI scans. The goal is to stratify the risk of clinically significant prostate cancer by utilizing machine learning techniques to analyze the results from these investigations. If any test indicates a high suspicion of clinically significant prostate cancer, participants will be offered an image-guided prostate biopsy for further evaluation. The study seeks to identify the most effective combination of tests for predicting prostate cancer risk.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 and older with a clinical suspicion of prostate cancer and specific PSA levels.
Not a fit: Patients with a prior history of prostate cancer or those who cannot undergo MRI or biopsy procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate detection of clinically significant prostate cancer, improving patient outcomes.
How similar studies have performed: Other studies utilizing AI-assisted diagnostic methods for cancer detection have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Hong Kong
- Prince of Wales Hospital, Chinese University of Hong Kong — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Principal investigator: Peter Ka-Fung CHIU, FRCS, PhD — Chinese University of Hong Kong
- Study coordinator: Peter Ka-Fung CHIU, FRCS, PhD
- Email: peterchiu@surgery.cuhk.edu.hk
- Phone: 35052625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer