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AI matches expert radiologists in spotting prostate cancer

NCT ID NCT06575361

Diagnosis 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tested whether an artificial intelligence (AI) system could help find prostate cancer on MRI scans. 365 men who needed a prostate biopsy had their MRI images reviewed by both the AI and by senior radiologists. Doctors then performed targeted biopsies on any suspicious areas found by either the AI or the radiologists. The goal was to see if the AI could detect clinically significant prostate cancer as accurately as the experts.

What this could mean

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

Active substance
MRI artificial intelligence (MRI-AI) software
What this could lead to
If successful, MRI-AI could help doctors find prostate cancer more accurately and reduce unnecessary biopsies.
What could go wrong
This is a completed study, but AI may not work as well in all hospitals or on different MRI machines. It also cannot replace a doctor's final judgment.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

365 people

The number who actually took part.

Started

Jan 2024

Finished

Aug 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.

Ages

45 to 85 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: * The age of the patient is between 45 and 85. * Patients with complete magnetic resonance imaging (MRI) data, qualified image quality control. * Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \>10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) \<0.16 or PSA density (PSAD) \>0.15. * Patients had no history of prior prostate surgery or biopsy. * The PSA of patients should be ≤20 ng/mL. * The prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate MRI examination should not exceed one month. * Patients with complete clinical information. Exclusion Criteria: * The clinicopathological information and MRI data was unqualified or incomplete. * Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy. * Patients received prior prostate biopsy. * Patients had contraindications to MRI or prostate biopsy. * Patients were not in accordance with the indication of prostate biopsy.

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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

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.