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A scanner in the operating room could show surgeons exactly where prostate cancer remains

NCT ID NCT07829068

Diagnosis Sponsor: University Hospital, Geneva 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Surgeons removing a prostate for cancer can struggle to tell cancerous tissue from healthy tissue, and cancer left at the edge of the removed gland is usually found only days later under a microscope. This pilot study at Geneva University Hospitals tests whether a PET/CT scanner placed in the operating room can image the freshly removed prostate and accurately show the location and extent of the cancer. Thirty participants with intermediate- or high-risk prostate cancer receive an injection of a radiotracer called gallium-68 PSMA-11 at the start of surgery, and researchers compare the scan images with the standard microscopic analysis. The scans do not change how the surgery is performed; the goal is to learn whether the technique is accurate and practical enough to test in future studies.

What this could mean

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

Active substance
gallium-68 PSMA-11 radiotracer with ex vivo PET/CT imaging of the prostate specimen
What this could lead to
If the images match the microscope findings, this could support future trials where surgeons use real-time scans to decide whether to remove more tissue during the same operation.
What could go wrong
This is a small pilot study of 30 people, and the scans will not change anyone's surgery. The technique may prove too imprecise or impractical to guide real-time decisions, and it adds radiation exposure for operating room staff.

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

30 people

The number who actually took part.

Started

May 2025

Expected to finish

Sep 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: * Diagnosis of intermediate- or high-risk prostate cancer. * Preoperative PSMA PET staging with positive uptake in the primary tumor. * Multidisciplinary approval by the urology tumor board for radical prostatectomy and study inclusion. * Capacity to provide informed consent Exclusion Criteria: * Refusal to participate or withdrawal from the study. * Inability to follow study procedures, for example because of language difficulties, psychological disorders or dementia. * Participation in another clinical trial requiring ex vivo prostate tissue for research. * Prior treatment that may alter PSMA uptake, such as androgen deprivation therapy or radiotherapy. * Variant prostate cancer histology, such as neuroendocrine cancer. * Insufficient-quality or unavailable PSMA PET images, including corrupted data, or an incomplete histopathology report.

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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.

Margin assessment Prostate cancer PSMA pet/CT

Contacts and locations

Locations

  • Hôpitaux Universitaires de Genève - Dept de Chirurgie - Service d'Urologie

    Geneva, Canton of Geneva, 1205, Switzerland

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