Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06360523

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

Led by Chinese University of Hong Kong · Updated on 2025-05-06

368

Participants Needed

1

Research Sites

198 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • Patient contraindicated to prostate biopsy
  • Patient failed to complete the biopsy procedure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

P

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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