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A sharper eye on prostate cancer: could new imaging spare healthy tissue?

NCT ID NCT07747493

Diagnosis Sponsor: University Health Network, Toronto 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This pilot study is testing whether a special PET/MRI scan using a radioactive tracer called 68Ga-PSMA-11 can better identify all areas of significant prostate cancer in men with localized disease. The goal is to improve selection for focal therapy, a treatment that targets only the cancerous part of the prostate, preserving urinary and sexual function. Participants will receive the tracer and undergo a PET/MRI before their planned prostate removal surgery. The imaging results will be compared with the actual tissue removed during surgery to see if the new scan finds more cancers than standard MRI alone.

What this could mean

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

Active substance
68Ga-PSMA-11 (a radioactive tracer used for PET imaging)
What this could lead to
If successful, this imaging approach could help doctors more accurately identify all areas of significant prostate cancer, potentially reducing the risk of incomplete treatment and preserving urinary and sexual function.
What could go wrong
This is a small pilot study with only 8 participants, so results may not apply broadly. The imaging technique may not prove more accurate than standard MRI, and there are risks associated with radiation exposure from the tracer.

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 8 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

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: * Ability to provide written informed consent. * Age 18 years or older. * Clinically significant prostate cancer (csPCa) with clinical stage ≤ T2c and planned radical prostatectomy. * Serum prostate-specific antigen (PSA) ≤ 20 ng/mL. * Clinically significant prostate cancer within an MRI-visible lesion, defined as - International Society of Urological Pathology (ISUP) Grade Group 2 or 3 (Gleason score 3+4 or 4+3) in any biopsy core. Exclusion Criteria: * Inability to lie still for the PET/MRI examination. * Known contraindication or hypersensitivity to gallium Ga 68 gozetotide (68Ga-PSMA-11) or to the MRI gadolinium contrast agent, including any component of the formulation.

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Conditions

The condition(s) this trial relates to.

adenocarcinoma prostate cancer

As listed by the trial registrant

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

Localized prostate cancer Prostate cancer (adenocarcinoma)

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 Health Network - Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

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