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RECRUITING
NCT06360523
NA

To Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

368

Start Date

2024-06-14

Completion Date

2028-03-31

Last Updated

2025-05-06

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

AI modal

The MRI image will be reviewed by radiologist and AI model(s) respectively. The urologist will combine the results of the two approaches to optimize the biopsy strategy which is expected to result in more accurate diagnosis.

DIAGNOSTIC_TEST

Standard review

The MRI image will be reviewed by radiologist.

Locations (1)

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong