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AI could spare thousands from unnecessary prostate biopsies

NCT ID NCT07614256

Diagnosis Sponsor: Guangxi Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether an artificial intelligence (AI) model can accurately predict which prostate cancers are aggressive and need treatment. Researchers will combine MRI and ultrasound images with tissue samples from 3,000 men. The goal is to reduce unnecessary biopsies and overdiagnosis of slow-growing cancers.

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 3,000 people

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

Started

May 2025

Expected to finish

Dec 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

This is a prospective and retrospective multicenter cohort study. The study population consists of consecutive male subjects aged 40-90 years who are scheduled to undergo or have undergone prostate biopsy or radical prostatectomy, with complete standard-of-care preoperative multiparametric MRI (mpMRI), transrectal ultrasound (TRUS) images, and corresponding pathological diagnosis results. The collected data include: 1. Preoperative mpMRI and TRUS images 2. Digital whole-slide images of prostate biopsy specimens 3. Digital whole-slide images of radical prostatectomy specimens (if performed) The prospective cohort will include newly enrolled subjects who provide written informed consent, while the retrospective cohort will include historical subjects with complete imaging, pathology slide, and clinical data from participating centers.

Ages

40 to 90 years

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: 1. Subjects who are scheduled to undergo or have undergone prostate biopsy or radical prostatectomy. 2. Subjects who have completed standard-of-care preoperative multiparametric MRI (mpMRI) and transrectal ultrasound (TRUS) examinations. 3. Subjects with complete pathological diagnosis results available. 4. Age between 40 and 90 years. 5. Able and willing to provide written informed consent (for prospective cohort participants only). Exclusion Criteria: 1. Prior history of pelvic radiation therapy or radical prostatectomy. 2. Incomplete or poor-quality mpMRI or TRUS images (e.g., motion artifacts, insufficient sequences). 3. Concurrent other primary malignant tumors. 4. Severe systemic diseases that may affect the evaluation of the prostate. 5. Subjects with incomplete clinical or pathological data. 6. Contraindications to MRI examination (e.g., incompatible metallic implants, severe claustrophobia).

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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.

Clinically significant prostate cancer 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

    1 site. 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

  • Liuzhou People's Hospital Affiliated to Guangxi Medical University

    RECRUITING

    Liuzhou, Guangxi, 545006, China

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