ProstateAI - A Prospective Paired Validating Cohort Study to Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Hong Kong Special Administrative Region
Prince of Wales Hospital, Chinese University of Hong Kong
RECRUITING
Hong Kong
Contact Information
Primary
Peter Ka-Fung CHIU, FRCS, PhD
peterchiu@surgery.cuhk.edu.hk
35052625
Time Frame
Start Date: 2024-06-14
Estimated Completion Date: 2028-03-31
Participants
Target number of participants: 368
Treatments
Experimental: AI review (index)
self-paired design, AI review (index)
Active_comparator: Radiologist review (Standard)
self-paired design, radiologist review (standard)
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong

This content was sourced from clinicaltrials.gov

Similar Clinical Trials