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AI takes on prostate cancer detection: could it replace the radiologist?

NCT ID NCT06298305

Diagnosis Sponsor: IRCCS San Raffaele 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an AI software called Quantib Prostate to see if it can detect prostate cancer on MRI scans as accurately as expert radiologists. Researchers looked at 200 men who had prostate MRIs and biopsies. The AI's readings were compared to the radiologist's readings, using biopsy results as the gold standard. The goal is to see if AI can speed up and improve prostate cancer diagnosis.

What this could mean

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

Active substance
Quantib Prostate software (AI-driven device for prostate MRI assessment)
What this could lead to
If successful, this AI tool could help radiologists read prostate MRIs faster and more accurately, potentially improving prostate cancer detection.
What could go wrong
This is a retrospective study with 200 patients, so results may not apply to all settings. The AI might not perform as well in real-world use or with different MRI machines.

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

200 people

The number who actually took part.

Started

Mar 2023

Finished

Sep 2024

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

A total of 200 patients who received mpMRI with endorectal coil at the Department of Radiology of the IRCCS Ospedale San Raffaele, Milan, Italy from January 2014 to January 2022 due to a clinical suspicion of PCa and subsequently underwent prostate biopsy will be retrospectively identified and will represent the study cohort.

Ages

18 years and older

Sex

Male participants only

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. Men at least 18 years of age referred with clinical suspicion of prostate cancer 2. Men who have undergone mpMRI and subsequent targeted plus random systematic prostate biopsies 3. Available pathological report with details regarding the site of positive cores and grade group 4. Serum PSA ≤ 20 5. Patient who underwent a 1.5T mpMRI with or without endorectal coil with the following protocol restrictions and according to recent European Guidelines, each case containing at least the following sequences, will be considered: T2w * No fat suppression * At least axial acquisition * Max voxel size 1.0x1.0x3.0mm DWI * At least on b-value ≥800 s/mm\^2 required, ≥1400 s/mm\^2 preferred * ADC map required * Max voxel size: 2.0x2.0x4.0mm * Axial scanning protocol only DCE scan * Recommended temporal resolution \<15s * Axial scanning protocol only Exclusion Criteria: NA

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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

Contacts and locations

Locations

  • IRCCS Ospedale San Raffaele

    Milan, MI, 20132, Italy

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