To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
- Conditions
- Prostate Cancer
- Registration Number
- NCT06360523
- Lead Sponsor
- Chinese University of Hong Kong
- Brief Summary
It is a prospective paired-cohort study for diagnostic test evaluation. The study aim to determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.
- Detailed Description
ProstateAI is a prospective paired-cohort study for diagnostic test evaluation. ProstateAI will determine the accuracy of AI review and investigate whether AI review could detect MRI visible significant cancer as effective as radiologist review. MRI image of about 368 men recommended for biopsy will be reviewed by an AI model and an experienced radiologist, respectively. AI review (index) and radiologist review (standard) will be blinded to each other, while biopsy urologists will be well-informed of the findings of both AI review and radiologist review and make personalized biopsy plan by combining both findings. The pathological results of MRI-ultrasound fusion biopsy (reference) will serve as the gold standard to assess the diagnostic accuracy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 368
- 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.
- Patient contraindicated to prostate biopsy
- Patient failed to complete the biopsy procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Prostate Cancer detection rate of ISUP grade group ≥2 Through study completion, an average of 1 year Assessed by AI review, Radiologist review, and Biopsy (Targeted).
- Secondary Outcome Measures
Name Time Method Diagnosis of any grade of prostate cancer Through study completion, an average of 1 year Assessed by prostate biopsy
Trial Locations
- Locations (1)
Prince of Wales Hospital, Chinese University of Hong Kong
🇭🇰Hong Kong, Hong Kong