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AI may help spot dangerous prostate cancer and spare men from needless biopsies

NCT ID NCT07760857

Diagnosis Sponsor: Chinese University of Hong Kong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study tests a new AI framework called Cad-MMFF that combines clinical information, ultrasound, and MRI images to better detect clinically significant prostate cancer. The goal is to see if this approach can reduce unnecessary biopsies and safely limit the use of MRI. The study involves Chinese men aged 50 and older who are suspected of having prostate cancer and are scheduled for a biopsy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
An AI-based diagnostic framework (Cad-MMFF) that combines clinical, ultrasound, and MRI data
What this could lead to
If successful, this AI tool could help doctors better identify clinically significant prostate cancer, sparing many men from unnecessary biopsies and MRIs.
What could go wrong
This is an early-stage study, and the AI's accuracy may not hold up in broader populations. It also depends on image quality and complete data, which may not always be available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The entire cohort of this study will be targeted at patients who are suspected of PCa and indicated for ultrasound-guided and/or MRI-guided targeted prostate biopsy. Brightness-modulated ultrasound data (longitudinal and transverse views with full prostate coverage), pathological outcomes (Gleason score, ISUP GG), pre-biopsy multi-parametric MRI scans, PI-RADS scores, patients demographics and clinical data, will be acquired from January 2023 to August 2026 retrospectively, and from September 2026 to March 2028 prospectively, from the existing database of the Picture Archiving and Communication System (PACS). Informed consent from subjects will be sought only for prospectively enrolled patients, while there will be no interventions involved given its nature of retrospective analysis

Ages

45 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ethnically Chinese men aged ≥ 50 * Suspicion of PCa \[elevated PSA (\>4-ng/ml) or abnormal DRE/PHI\] and indicated for prostate biopsy * Obtained clinical consent (for prospectively enrolled patients only) Exclusion Criteria: * Prior biopsy/treatments for PCa * History of genitourinary cancer * Poor image quality * Incomplete imaging scans/clinical data/pathological results

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Conditions

The condition(s) this trial relates to.

disease prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer (diagnosis)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • North District Hospital

    Sheung Shui, Hong Kong

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

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