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AI reads MRIs to spot dangerous prostate cancers without a needle

NCT ID NCT06842264

Knowledge-focused Sponsor: Peking University First Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to develop and test an AI model that analyzes prostate MRI scans to predict whether a cancer is aggressive (clinically significant). Researchers will use data from 3,000 patients who had both an MRI and a biopsy. The goal is to create a tool that helps doctors decide who really needs a biopsy, reducing unnecessary procedures.

What this could mean

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

What this could lead to
If successful, this could lead to a more accurate, non-invasive way to predict aggressive prostate cancer, potentially reducing the need for biopsies.
What could go wrong
This is an observational study using existing data, so it cannot prove the AI model works in real-time. The results may not apply to all patients or hospitals.

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

Jan 2024

Expected to finish

Dec 2029

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

Patients who underwent prostate magnetic resonance imaging (MRI) at Peking University First Hospital between January 2024 and December 2029, followed by an ultrasound-guided prostate biopsy.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * The interval between prostate MRI and biopsy within 3 months * Integrity of related data Exclusion Criteria: * PSA less than 50ng/ml * Any treatment for PCa prior to either MRI or biopsy, including radical prostatectomy, radiotherapy, chemotherapy, and endocrine therapy * Previous history of surgical treatment or 5α-reductase inhibitor therapy for benign prostatic hyperplasia * Subjects undergoing MRI with an indwelling urinary catheter or suprapubic catheter * Inadequate quality of MRI images

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

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

Prostate cancer

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

  • Peking University First Hospital

    RECRUITING

    Beijing, 100034, China

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