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A sharper eye on prostate cancer return: PSMA PET vs. MRI

NCT ID NCT07766122

Diagnosis Sponsor: University Hospital, Toulouse 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Last updated Aug 14, 2026

Summary

This pilot study investigates whether a PSMA PET scan, using an injected radiotracer, can detect clinically significant prostate cancer recurrence one year after focal HIFU treatment, compared with the standard MRI. About 30 men with prostate cancer who meet specific criteria will undergo both imaging tests, followed by a prostate biopsy as the gold standard to confirm any recurrence. The goal is to see if PSMA PET is as accurate as MRI in spotting cancer that has come back, which could improve monitoring after focal therapy.

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 scan with an injected radiotracer
What this could lead to
If PSMA PET proves as accurate as MRI, it could offer a more reliable way to detect prostate cancer recurrence after focal therapy, potentially guiding earlier and more precise follow-up care.
What could go wrong
This is a small pilot study, so results may not be conclusive. PSMA PET might not match MRI's accuracy, and the radiotracer injection carries minor risks like allergic reactions or radiation exposure.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

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.

Ages

70 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: * Patient with prostate cancer * Age ≥ 70 years (HAS 2023) * Life expectancy \> 5 years * Clinical stage Clinical stage T1c - T2a PSA \< 20 ng/ml Biopsy :ISUP 2 unilateral on a maximum of 2 contiguous sextants with or without ipsilateral or contralateral focus ISUP1 single focus or multiple foci if only one ISUP 2 focus on targeted biopsy * Imaging Single lesion PIRADS 3 or 4 or 5 Volume of prostate gland \< 150 ml * Enrolled in a social security scheme * Signature of consent Exclusion Criteria: * Evidence of extra-prostatic extension or invasion of the seminal vesicles. * Any condition that, in the judgement of the investigators, would interfere with the subject's ability to * provide informed consent, comply with study instructions, expose the subject to increased risk, or interfere with the interpretation of study results. * Patients deprived of their liberty or under legal protection (curatorship and guardianship, safeguard of justice) * Hypersensitivity to the active substances or to any of the excipients * Conditions contraindicating magnetic resonance imaging (MRI), such as the presence of internal metallic devices. * Chronic kidney disease with an eGFR ≤ 60 mL/min * Liver failure

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Conditions

The condition(s) this trial relates to.

disease hormone-resistant prostate carcinoma prostate cancer Recurrence

As listed by the trial registrant

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

Prostate cancer (diagnosis) Prostate cancer recurrent

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

  • University Hospital of Toulouse

    Toulouse, France

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