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NCT06360523Not yet recruiting

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
Chinese University of Hong KongClinicalTrials.govdiagnostic test
Verified
Study focus
Disease/Condition
Prostate Cancer
Drug/Device/Intervention
AI modal
Study type
Observational
Intervention type
diagnostic test
Sponsor & location
Primary sponsor
Chinese University of Hong Kong
Location
Hong Kong, China
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
Jul 20, 2025
Enrollment
102 participants
Primary outcome

Prostate Cancer detection rate of ISUP grade group ≥2

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 102 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.

ICD-10 classifications
Malignant neoplasm of prostateHyperplasia of prostateDisorder of prostate, unspecifiedOther disorders of prostateCarcinoma in situ: Prostate
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06360523
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06360523 through Pure Global AI's free database. This phase not specified trial is sponsored by Chinese University of Hong Kong and is currently Not yet recruiting. The study focuses on Prostate Cancer. Target enrollment is 102 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.