Actively Recruiting

Age: 18Years +
MALE
Healthy Volunteers
NCT05443412

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

Led by Chinese University of Hong Kong · Updated on 2025-05-20

510

Participants Needed

1

Research Sites

169 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men 18 years of age or older
  • Clinical suspicion of prostate cancer
  • Serum Prostate-specific antigen (PSA) between 4 and 20 ng/mL
  • Digital rectal examination showing organ confined cancer (cT2 or less)
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • Prior prostate biopsy
  • Past or current history of prostate cancer
  • Unable to undergo plain MRI scan (e.g., pacemaker, claustrophobia)
  • Unable to have transperineal prostate biopsy due to active urinary infection, failed TRUS probe insertion or lithotomy position, uncorrectable bleeding disorders, or unstop­pable antiplatelet/anticoagulant therapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

P

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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