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Smart AI could slash unnecessary prostate biopsies

NCT ID NCT06589154

Diagnosis Sponsor: Shanghai Changzheng Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This completed study tested an artificial intelligence model called BEAM that combines MRI scans with a blood test (cell-free DNA) to improve prostate cancer diagnosis. Over 1,600 men participated, including those with healthy prostates, benign enlargement, or prostate cancer. The goal was to see if the AI could more accurately predict cancer than current PSA tests, potentially reducing the need for invasive biopsies.

What this could mean

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

Active substance
Multi-modal artificial intelligence model (BEAM) combining mpMRI and cfDNA analysis
What this could lead to
If successful, this AI tool could help doctors more accurately detect prostate cancer and avoid unnecessary biopsies, especially for men with borderline PSA levels.
What could go wrong
This is a completed study, but the AI model's real-world performance may vary. It was tested against biopsy results, and further validation is needed before routine use.

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

1,651 people

The number who actually took part.

Started

Oct 2024

Finished

Jul 2025

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

People who are required to undergo prostatic or pelvic magnetic resonance (MR) examination

Ages

18 to 80 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Men aged 18-80 years with a clinical indication for prostate or pelvic magnetic resonance (MR) examination. * Patients with normal prostate, benign prostatic hyperplasia, or prostate cancer. * First visit on January 1, 2014, or later. Exclusion Criteria: * Diagnosis of any other malignancy within the previous 5 years. * Prior transurethral resection or enucleation of the prostate before imaging. * Any condition deemed by the investigator to make the patient unsuitable for study participation.

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Conditions

The condition(s) this trial relates to.

benign prostatic hyperplasia prostate cancer

As listed by the trial registrant

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

Benign prostatic hyperplasia Healthy people Prostate cancer

Contacts and locations

Locations

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021, China

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433, China

  • Jiangsu Provincial People's Hospita

    Nanjing, Jiangsu, 210029, China

  • Ningbo No. 1 Hospita

    Ningbo, Zhejiang, 315010, China

  • Northern Jiangsu People's Hospita

    Yangzhou, Jiangsu, 225001, China

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 201209, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Zhongda Hospital, Southeast University

    Nanjing, Jiangsu, China

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