RecruitingNot ApplicableNCT06360523

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

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

Sponsor

Chinese University of Hong Kong

Enrollment

368 participants

Start Date

Jun 14, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new artificial intelligence (AI)-powered pathway for diagnosing prostate cancer using MRI scans. Currently, not all men who need prostate biopsies get an MRI first. This trial tests whether using AI alongside the MRI and radiologist review improves diagnostic accuracy and reduces unnecessary biopsies. **You may be eligible if...** - You are a man aged 18 or older - Your doctor has recommended a prostate biopsy for diagnosis or re-evaluation - You have a prostate MRI scan that can be reviewed by both a radiologist and the AI system - You have signed informed consent **You may NOT be eligible if...** - You have a medical reason (contraindication) that prevents you from having a prostate biopsy - You were unable to complete the biopsy procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTAI 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_TESTStandard review

The MRI image will be reviewed by radiologist.