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

Not Applicable
Recruiting
Conditions
Prostate Cancer
Registration Number
NCT06360523
Lead Sponsor
Chinese University of Hong Kong
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Male
Target Recruitment
368
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.
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Exclusion Criteria
  • Patient contraindicated to prostate biopsy
  • Patient failed to complete the biopsy procedure
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Prostate Cancer detection rate of ISUP grade group ≥2Through study completion, an average of 1 year

Assessed by AI review, Radiologist review, and Biopsy (Targeted).

Secondary Outcome Measures
NameTimeMethod
Diagnosis of any grade of prostate cancerThrough study completion, an average of 1 year

Assessed by prostate biopsy

Trial Locations

Locations (1)

Prince of Wales Hospital, Chinese University of Hong Kong

🇭🇰

Hong Kong, Hong Kong

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