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New MRI Add-On aims to sharpen prostate cancer detection

NCT ID NCT06985238

Diagnosis Sponsor: Stratagen Bio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 whether adding a special MRI scan to the standard prostate exam is safe and can collect useful data. About 75 men aged 40-90 with elevated PSA levels will get up to 15 extra minutes of scanning. The goal is to see if the new platform causes any serious problems and if it can produce clear images to help find prostate cancer.

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

About 75 people

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

Started

Sep 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 90 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: * Subject has a prostate that would be considered for biopsy * Age 40-90 years * PSA ≥ 2.5 * Subject has been informed of the nature of the study and has provided written informed consent Exclusion Criteria: * Contraindication for MRI * Prostate biopsy within the previous 12 weeks * Implant in the pelvis that may cause artifact on MRI (e.g. hip replacement) * History of prostatectomy or other local prostate cancer therapy (e.g., cryotherapy or brachytherapy), or previous pelvic irradiation * Currently enrolled in another investigational drug or device study that clinically interferes with this study * Unable to comply with the study requirements or follow up schedule * Any condition the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the subject

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Urology Clinic at Sawgrass

    RECRUITING

    Rochester, New York, 14620, United States

  • Virginia Urology

    RECRUITING

    Richmond, Virginia, 23235, United States

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