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Double scan strategy could sharpen prostate cancer staging

NCT ID NCT07455097

Diagnosis Sponsor: Heinrich-Heine University, Duesseldorf 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether combining PSMA-PET/CT and MRI scans can more accurately determine the extent of prostate cancer in men with intermediate- or high-risk disease. Researchers will compare scan results with tissue samples from 600 men who had their prostate removed. The goal is to improve staging and guide personalized treatment decisions.

What this could mean

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

Active substance
PSMA-11 (diagnostic tracer)
What this could lead to
If successful, this could lead to more accurate staging of prostate cancer, helping doctors choose better treatments and avoid unnecessary surgery.
What could go wrong
This is a retrospective analysis, not a controlled trial, so results may not apply to all patients. The imaging techniques are already in use, so the benefit may be modest.

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 600 people

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

Started

Jan 2026

Expected to finish

Dec 2026

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

Men at intermediate risk (PSA \> 10 ng/ml to 20 ng/ml or Gleason score 7 or cT category 2b) or high risk (PSA \> 20 ng/ml or Gleason score ≥ 8 or cT category 2c) who underwent PSMA-PET/CT and mpMRI and subsequentially RP will be analyzed in three different subgroups, assigned to the modalities they underwent in staging in addition to MRI: i) PSMA-PET/CT using 18-F-DCFPyL (subgroup/arm A), ii) PSMA-PET/CT using Gallium-68 (subgroup/arm B) and PSMA-PET/CT using Fluorine-18 (subgroup/arm C). Validation of the accuracy of intraprostatic lesion detection, local staging and of LN-Staging by MRI or PSMA-PET/CT with different tracers is confirmed after radical prostatectomy.

Ages

45 to 80 years

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. Men aged from 45 to 80 years 2. Men with intermediate risk or high risk csPCa 3. Men who underwent RP 4. Men who underwent multiparametric MRI and PSMA-PET/CT before RP Exclusion Criteria: a) Men with known prostate cancer, who did not underwent RP and who did not underwent MRI or PSMA-PET-CT

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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.

High-risk prostate cancer Intermediate risk prostate cancer

Contacts and locations

Locations

  • Fortis Hospital

    Kolkata, India

  • KU Leuven

    Leuven, Belgium

  • Ludwig-Maximilians-University Munich

    Munich, Germany

  • Lund University Hospital

    Lund, Sweden

  • Marienhospital Herne

    Herne, Germany

  • Medical University Vienna

    Vienna, Austria

  • San Raffaele University Hospital Milan

    Milan, Italy

  • University Hospital Bern

    Bern, Switzerland

  • University Hospital Düsseldorf

    Düsseldorf, 40225, Germany

  • University Hospital Tübingen

    Tübingen, Germany

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