ProstateAI - A Prospective Paired Validating Cohort Study to Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 368
- Locations
- 1
- Primary Endpoint
- Prostate Cancer detection rate of ISUP grade group ≥2
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Care Provider)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AI review (index)
self-paired design, AI review (index)
Intervention: AI modal (Diagnostic Test)
Radiologist review (Standard)
self-paired design, radiologist review (standard)
Intervention: Standard review (Diagnostic Test)
Outcomes
Primary Outcomes
Prostate Cancer detection rate of ISUP grade group ≥2
Time Frame: Through study completion, an average of 1 year
Assessed by AI review, Radiologist review, and Biopsy (Targeted).
Secondary Outcomes
- Diagnosis of any grade of prostate cancer(Through study completion, an average of 1 year)
Investigators
CHIU Ka Fung Peter
Associate Professor
Chinese University of Hong Kong