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Search / Trial NCT05443412

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

Launched by CHINESE UNIVERSITY OF HONG KONG · Jun 30, 2022

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how artificial intelligence (AI) can help detect prostate cancer more effectively in men who are at risk. The researchers want to learn if using AI technology alongside urine and blood tests, as well as special ultrasound and MRI scans, can better identify significant prostate cancer that needs treatment. The trial is currently looking for 510 men aged 18 and older who have signs that they might have prostate cancer, particularly those with specific levels of a blood marker called PSA.

To join the study, participants should not have had a prostate biopsy before and should not have a history of prostate cancer. They also need to be able to undergo an MRI scan. Those who take certain medications that affect blood clotting or have other medical conditions that could complicate the tests may not be eligible. If you participate, you can expect to undergo several tests to assess your risk for clinically important prostate cancer, and the information gathered will help researchers understand how to improve cancer detection in the future.

Gender

MALE

Eligibility criteria

  • Inclusion Criteria:
  • Men ≥18 years of age
  • Clinical suspicion of prostate cancer
  • Serum Prostate-specific antigen (PSA) 4-20 ng/mL
  • Digital rectal examination ≤ cT2 (organ confined cancer)
  • Able to provide written informed consent
  • Exclusion Criteria:
  • Prior prostate biopsy
  • Past or current history of prostate cancer
  • Contraindicated to undergo plain MRI scan (e.g. pacemaker in-situ, claustrophobia)
  • Contraindicated to transperineal prostate biopsy: active urinary tract infection, fail TRUS probe insertion or lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped

About Chinese University Of Hong Kong

The Chinese University of Hong Kong (CUHK) is a prestigious research institution renowned for its commitment to advancing medical science and improving healthcare outcomes. As a clinical trial sponsor, CUHK leverages its extensive academic resources and interdisciplinary expertise to conduct innovative research that addresses critical health challenges. The university fosters collaboration among leading researchers, healthcare professionals, and industry partners, ensuring rigorous study design and implementation. CUHK is dedicated to upholding the highest ethical standards in clinical research, with a focus on translating findings into tangible benefits for patients and the broader community.

Locations

Hong Kong, , Hong Kong

Patients applied

0 patients applied

Trial Officials

Peter Ka-Fung CHIU, FRCS, PhD

Principal Investigator

Chinese University of Hong Kong

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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