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Can a special scan better detect prostate cancer recurrence after HIFU?

NCT ID NCT07184970

Diagnosis Sponsor: NYU Langone Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Updated 3 times

Summary

This study will test whether a special type of scan called PSMA PET/MRI can find prostate cancer that comes back after a treatment called High-Intensity Focused Ultrasound (HIFU) better than a standard MRI. About 60 men who had HIFU for prostate cancer will get both scans one year later, and the results will be compared to a biopsy. The goal is to see if the new scan catches more recurrences, which could help guide further treatment.

What this could mean

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

Active substance
PSMA PET/MRI imaging
What this could lead to
If successful, this could show that PSMA PET/MRI is better than standard MRI at finding prostate cancer that comes back after HIFU treatment, helping doctors choose the right next steps.
What could go wrong
This is a small, early-stage study with only 60 participants, so results may not apply to everyone. The imaging technique may not prove more accurate than existing methods.

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 60 people

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

Started

Oct 2025

Expected to finish

Oct 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

Only male patients will be included in this study. The expected age range will be 40-95. There is no enrollment restrictions based upon race or ethnic origin.

Ages

40 to 95 years

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: * Male patients 40-95 years of age with biopsy-confirmed localized prostate cancer. * Grade Group ≥2 (Gleason score 3+4 or higher). * Unifocal disease visible on mpMRI. * Patients undergoing HIFU as part of their standard of care * PSA \<20 ng/mL. * No metastatic disease on PSMA PET/CT * Willingness to comply with follow-up protocols (PSA testing, imaging, biopsies). Exclusion Criteria: * Evidence of metastatic disease on PSMA PET/CT. * Allergy to POSLUMA or gadolinium. * Inability to tolerate MRI due to claustrophobia or posture/back-hip issues.

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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

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

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