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AI reads prostate scans to catch dangerous cancers and skip needless biopsies

NCT ID NCT06804785

Diagnosis Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

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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
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 Results may not be published yet.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 This study
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

Researchers at Northwestern University are testing an artificial intelligence tool that reads prostate MRI scans to find suspicious lesions. The goal is to see whether this AI can detect clinically significant prostate cancer as well as or better than the standard PIRADS scoring system. Men with elevated PSA or an abnormal rectal exam who have not had a biopsy may take part. If the AI proves reliable, it could speed up diagnosis and help some men avoid 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
An artificial intelligence tool that reads prostate MRI scans to flag suspicious lesions
What this could lead to
If it works, this AI could help doctors find aggressive prostate cancer earlier and spare many men from unnecessary biopsies.
What could go wrong
The tool is still being tested against standard reading, and it may not prove more accurate in real-world use. Early results may not hold up in larger, more diverse groups.

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.

Expected to start

Aug 2025

An estimate. Start dates often move.

Expected to finish

May 2028

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 at an increased risk of having prostate cancer. An increased risk for prostate cancer means the patient may have had either a blood test which indicated they have an elevated prostate-specific antigen (PSA) (a protein produced by both cancerous and noncancerous tissue in the prostate), or an abnormal exam of the patient's rectum, anus or prostate gland.

Ages

18 to 89 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: * Elevated PSA (4.0-10.0 ng/ml) or abnormal digital rectal exam with PSA of 2.00-10.00 ng/ml as indicated in the patient's lab report. * Patients must be biopsy naïve, confirmed with patient or medical record. * Patients must be male, ≥18 and ≤ 89 years of age. * Patient must have a life expectancy ≥10 years, determined by PI. * Patients must exhibit an ECOG performance status of 0-2, as noted in their medical record. Exclusion Criteria: * Patients who are on a 5-α-reductase inhibitor within 12 months of enrollment, as confirmed by medical record. * Patients who have had a prostate infection within 1 month of enrollment, as confirmed by medical record. * Patients who are receiving or who received prostate cancer treatment (e.g., androgen deprivation therapy, surgery, radiation therapy or adjuvant/neoadjuvant therapy with investigational drugs) per their medical record. * Patients who've had an invasive urological procedure within 1 month of enrollment, as confirmed by their medical record and patient reporting. * Patients with no access to the rectum for a transrectal ultrasound, as determined by the Urologist. * Patients with a contraindication to magnetic resonance imaging (MRI). * Vulnerable populations: Prisoners or adult men \>89 years old.

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Conditions

The condition(s) this trial relates to.

neoplasm 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

  • National Institutes of Health

    Bethesda, Maryland, 20892, United States

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