Evaluating AI for prostate cancer diagnosis using MRI
ProstateAI - A Prospective Paired Validating Cohort Study to Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
This study is testing whether an artificial intelligence tool can accurately analyze MRI images of prostate cancer to help doctors make better decisions about biopsies for men at risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 368 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06360523 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the accuracy of an artificial intelligence (AI) model in reviewing MRI images of prostate cancer compared to traditional radiologist reviews. Approximately 368 men recommended for biopsy will have their MRI images analyzed by both the AI and an experienced radiologist, with both reviews conducted independently. The findings from these reviews will inform personalized biopsy plans made by urologists, who will also consider the results from MRI-ultrasound fusion biopsies as the gold standard for accuracy assessment. The study seeks to determine if AI can effectively detect significant cancers visible on MRI.
Who should consider this trial
Good fit: Ideal candidates include men aged 18 and older who are recommended for a prostate biopsy and have MRI images suitable for review.
Not a fit: Patients who are contraindicated to prostate biopsy or who fail to complete the biopsy procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnoses, leading to better-targeted treatments for patients.
How similar studies have performed: While the use of AI in medical imaging is a growing field, this specific approach to prostate cancer diagnosis using MRI and AI is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients recommended for prostate biopsy for diagnosis or re-assessment. * Men at least 18 years or over * Patients with prostate MRI image eligible for radiologist review and AI review. * Patient Informed Consent is signed. Exclusion Criteria: * Patient contraindicated to prostate biopsy * Patient failed to complete the biopsy procedure
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 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.