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Clinical trial Recruiting at 1 site Interventional Ages 18 and up Men only

Evaluating AI for prostate cancer diagnosis using MRI

Official title: ProstateAI - A Prospective Paired Validating Cohort Study to Evaluate an MRI-based Optimized Prostate Cancer Diagnostic Pathway Powered by Artificial Intelligence

Run by Chinese University of Hong Kong · NCT06360523 · Data updated 2026-11-12

This study is testing whether an artificial intelligence tool can accurately analyze MRI images of prostate cancer to help doctors make better decisions about biopsies for men at risk.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment629 (estimated)
SponsorChinese University of Hong Kong
Academic / other
Locations1 site (Hong Kong)
StatusRecruiting
StartedJune 14, 2024
Main results expectedDecember 31, 2028
Study endsMarch 31, 2029
Registry record updatedNovember 3, 2026
Trial IDNCT06360523 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include men aged 18 and older who are recommended for a prostate biopsy and have MRI images suitable for review.

Probably not a fit

Patients who are contraindicated to prostate biopsy or who fail to complete the biopsy procedure may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the accuracy of an artificial intelligence (AI) model in reviewing MRI images of prostate cancer compared to traditional radiologist reviews. Approximately 368 men recommended for biopsy will have their MRI images analyzed by both the AI and an experienced radiologist, with both reviews conducted independently. The findings from these reviews will inform personalized biopsy plans made by urologists, who will also consider the results from MRI-ultrasound fusion biopsies as the gold standard for accuracy assessment. The study seeks to determine if AI can effectively detect significant cancers visible on MRI.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnoses, leading to better-targeted treatments for patients.

How similar studies have gone: While the use of AI in medical imaging is a growing field, this specific approach to prostate cancer diagnosis using MRI and AI is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Exclusion Criteria:

* Patient contraindicated to prostate biopsy
* Patient failed to complete the biopsy procedure

Where it's running

  • Prince of Wales Hospital, Chinese University of Hong Kong
    Hong Kong, Hong Kong     Recruiting

Study contacts

  • Principal investigator: Peter CHIU, FRCS, PhD — Chinese University of Hong Kong
  • Study coordinator: Peter Ka-Fung CHIU, FRCS, PhD
  • Email: peterchiu@surgery.cuhk.edu.hk
  • Phone: 35052625

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.