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Artificial Intelligence (AI)-Assisted Risk-based Prostate Cancer Detection

NCT05443412 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 510

Last updated 2025-05-20

No results posted yet for this study

Summary

This is a prospective clinical study recruiting 510 men at risk of PCa to undergo urine, blood, AI-assisted ultrasound and AI-assisted MRI investigations to stratify risk of clinically significant PCa (csPCa). (sample size calculation in section 5)

Conditions

Interventions

DIAGNOSTIC_TEST

Diagnostic test for prostate cancer

All recruited patients will undergo investigations including urine for spermine, blood for miRNA, TRUS, and MRI prostate. Patients with high suspicion of Clinically significant prostate cancer in any one step (urine, blood, ultrasound, OR MRI) will be offered an image-guided prostate biopsy.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Peter Ka-Fung CHIU, FRCS, PhD · Chinese University of Hong Kong

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2026-07-31
Completion
2026-10-30

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05443412 on ClinicalTrials.gov