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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: AI modal; Diagnostic Test: Standard review

Study type: Interventional

Funder types: Other

Identifiers

NCT06360523

CRE-2024.141

Details and patient eligibility

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.

Full 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.

Enrollment: 368 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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368 participants in 2 patient groups

AI review (index)

Experimental group

Description:

self-paired design, AI review (index)

Treatment:

Diagnostic Test: AI modal

Radiologist review (Standard)

Active Comparator group

Description:

self-paired design, radiologist review (standard)

Treatment:

Diagnostic Test: Standard review