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New flexible MRI coil could spare men unnecessary prostate biopsies

NCT ID NCT05043012

Diagnosis Sponsor: M.D. Anderson Cancer Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 14, 2026 · Updated 2 times

Summary

This study is testing whether a new flexible MRI coil can accurately detect significant prostate cancer in 258 men with intermediate or high-risk disease. The goal is to see if this less invasive approach can reduce the number of unnecessary biopsies. Participants will receive both the standard and the new MRI scan to compare results.

What this could mean

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

Active substance
flexible AIR coil
What this could lead to
If successful, this could make prostate MRI scans more comfortable and accessible, potentially reducing the need for invasive biopsies.
What could go wrong
This is an early-stage diagnostic study, not a treatment trial. The new coil may not be as accurate as the standard endorectal coil, and results may not apply to all patients.

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 258 people

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

Started

Jul 2022

Expected to finish

Feb 2027

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.

Ages

18 years and older

Sex

Anyone

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: * Male, Age ≥ 18 * Untreated, biopsy-proven with intermediate and high-risk (Gleason group grade \>/=2) adenocarcinoma of the prostate * Patient is being considered for curative-intent treatment with radical prostatectomy within 6 months following mpMRI * Patient has provided written informed consent for participation in this trial * Patient should be eligible for scanning at 3 T magnet Exclusion Criteria: * Low-risk adenocarcinoma of prostate * Patient has had any prior therapy for prostate cancer * A history of other active malignancy within the last 2 years * Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components * Cardiac pacemaker * Orthopedic hardware in the pelvis and spine. * Claustrophobia and/or receiving anesthesia * Contraindication for endorectal coil such as rectal bleeding, severe anal fissures or hemorrhoids, anal/rectal surgery, and lack of rectum.

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

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

    1 site. 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

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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