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New MRI-Ultrasound fusion aims to sharpen prostate cancer detection

NCT ID NCT05064111

Diagnosis Sponsor: University of Arizona 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new software that combines MRI images with real-time ultrasound to guide prostate biopsies. The goal is to help doctors more accurately detect and locate aggressive prostate cancer early. About 100 men scheduled for a standard prostate biopsy will take part. The research focuses on improving diagnosis, not on treating the cancer itself.

What this could mean

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

Active substance
image fusion software
What this could lead to
If successful, this could make prostate cancer biopsies more accurate, helping doctors find aggressive cancers earlier and choose better treatments.
What could go wrong
This is an early-stage study testing a software add-on, not a new treatment. The trial is currently suspended, and the software is not yet FDA-approved, so results may not lead to immediate changes in practice.

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 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 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

Adult male patients undergoing diagnostic work up for suspected or recurrent prostate cancer as standard of care.

Ages

18 years and older

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: 1. Able to give informed consent 2. Male - age \> 18 3. mpMRI within the previous 6 months (PIRADS 3,4,5, all stages of PCa) 4. Scheduled for TRUS biopsy for prostate lesion or mass Exclusion Criteria: 1. Age under 18 years of age. 2. Female 3. Pre-existing blood dyscrasias 4. Inability to perform TRUS due to anal sphincter closure/surgery 5. Patients needing general anesthesia 6. Patients allergic to lidocaine 7. Patients allergic or unable to take antibiotics

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Prostate adenocarcinoma 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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • University of Arizona

    Tucson, Arizona, 85724, United States

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