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New imaging agent could sharpen prostate cancer staging

NCT ID NCT06122584

Diagnosis Sponsor: ABX advanced biochemical compounds GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial is testing whether a radioactive tracer called [18F]PSMA-1007 can improve PET/CT scans for men with newly diagnosed high-risk or very-high-risk prostate cancer. The goal is to see if it can more accurately detect cancer that has spread to pelvic lymph nodes. About 380 men will receive the tracer before undergoing prostate removal surgery, and the scan results will be compared with tissue samples.

What this could mean

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

Active substance
[18F]PSMA-1007 (a radioactive tracer for PET scans)
What this could lead to
If successful, this could provide a more accurate way to detect cancer spread in lymph nodes, helping doctors plan better treatment for high-risk prostate cancer.
What could go wrong
This is a diagnostic study, not a treatment. The tracer may not prove more accurate than current methods, and results depend on comparison with surgical tissue samples.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 380 people

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

Started

Jun 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. The patient (male) is aged 18 years or above. 2. The patient is able to understand the information presented to him concerning the nature, scope, and consequences of the trial as set out in the information provided to the patient AND has provided written informed consent to participate. 3. The patient has newly diagnosed, biopsy-proven, clinically localized prostate adenocarcinoma, and curative prostatectomy with extended pelvic lymph node dissection is his preferred course of treatment. 4. The patient has at least high-risk disease as defined by the NCCN guidelines (version 1.2023). That is, the presence of any one or more of the following: * Overall ISUP grade group 4 or 5, * Clinical category T3a or greater, * Serum PSA level greater than 20 ng/ml. 5. The patient has undergone conventional imaging (CT or MRI, and bone scan if clinically indicated) to detect the presence of pelvic nodal involvement and bone or visceral metastases within 60 days of the planned PET-CT procedure. Exclusion Criteria: 1. Patients for whom radical prostatectomy is not clinically appropriate or the patient is otherwise unlikely to undergo radical prostatectomy with extensive pelvic lymph node dissection. 2. The patient has received any therapy - be it radiation, surgical or drug therapy - for his prostate cancer. 3. The patient has any contraindication(s) for and/or known hypersensitivity to any constituent(s) of \[18F\]PSMA-1007. 4. The patient is not able to have PET-CT scans (for example, because of weight, claustrophobia, or inability to lie still for the duration of the scan). 5. The patient is closely affiliated to the investigation site; e.g. is a first-degree relative of the investigator. 6. At the time of screening, the patient is receiving any other investigational agent(s), or he has received any such agent(s) within the previous 30 days, or he is scheduled to receive any such agent(s) in the period up to the planned date for the last study visit. 7. The patient has previously been enrolled in this trial. 8. The patient has previously undergone PET imaging with any PSMA-avid product. 9. The patient has histological evidence of small-cell carcinoma of the prostate. 10. The patient is clinically unstable or requires emergency treatment. 11. The patient has any mental condition rendering him incapable of understanding the nature, scope, and consequences of the trial as set out in the information given to the patient.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

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

    16 sites in 6 countries. 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

  • CHRU de Nancy

    RECRUITING

    Nancy, France

  • CWZ

    RECRUITING

    Nijmegen, Netherlands

  • Carl Gustav Carus Faculty of Medicine, TUD Dresden

    RECRUITING

    Dresden, Germany

  • Hospital Del Mar

    RECRUITING

    Barcelona, Spain

  • Hospital Vall d'Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Vithas Valencia 9 de Octubre

    ACTIVE_NOT_RECRUITING

    Valencia, Spain

  • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

    RECRUITING

    Meldola, Italy

  • IRCCS Ospedale Sacro Cuore-Don Calabria

    RECRUITING

    Verona, Italy

  • Klinikum rechts der Isar, TUM

    ACTIVE_NOT_RECRUITING

    München, Germany

  • National Cancer Center

    RECRUITING

    Tokyo, Japan

  • Radboud UMC

    RECRUITING

    Nijmegen, Netherlands

  • St. Antonius Hospital

    RECRUITING

    Gronau, Germany

  • The University of Osaka Hospital

    RECRUITING

    Osaka, Japan

  • University Hospital Düsseldorf

    RECRUITING

    Düsseldorf, Germany

  • University Hospital Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

  • University Hospital Leipzig

    RECRUITING

    Leipzig, Germany

  • University Hospital Münster

    RECRUITING

    Münster, Germany

  • Universitätsmedizin Rostock

    RECRUITING

    Rostock, Germany

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