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Taking people in GermanyNo phase

PSMA imaging scan for staging prostate cancer in routine care

Studies how a PSMA scan helps stage prostate cancer in adults.

Plain-language title generated from the registry record
Registry title: Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer

Key facts

Where
Düsseldorf, GermanySee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a first diagnosis of prostate cancer who are planned to have an [18F]PSMA-1007 PET/CT scan.

Age
Over 18 years
Sex
Men only
Disease stage
First diagnosis of prostate cancer (primary staging).

Main reasons for not taking part

  • Scans that cannot be assessed well because of technical errors, such as imaging artifacts

Read by machine on 12 November 2026.

Where in Germany

  • Heinrich Heine University, Medical Faculty, University Hospital DüsseldorfDüsseldorf, GermanyContact: Frederik Lars Giesel, Univ.-Prof. Dr. med.Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Heinrich-Heine University, Duesseldorf
Trial code
NCT06820333
Record updated
11 February 2025
Original description
The introduction of PSMA diagnostics and therapy has fundamentally changed the treatment management of prostate cancer and has significantly replaced other clinical and radiological diagnostic methods. As a result, 18F-PSMA-1007 (Radelumin®) was approved in Germany and several EU countries, most recently in Germany in 01/2024, for use in primary staging of high-risk prostate cancer and re-staging in the context of biochemical recurrence (BCR). This could be seen as a milestone in the management of prostate cancer and will significantly promote the widespread use of PSMA-PET diagnostics in the coming years.Read full original descriptionShow less

The Clinical Impact and Prognostic Value of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer: Real-world Evidence From a Monocentric, Prospective Observational Study

The introduction of PSMA diagnostics and therapy has fundamentally changed the treatment management of prostate cancer and has significantly replaced other clinical and radiological diagnostic methods. As a result, 18F-PSMA-1007 (Radelumin®) was approved in Germany and several EU countries, most recently in Germany in 01/2024, for use in primary staging of high-risk prostate cancer and re-staging in the context of biochemical recurrence (BCR). This could be seen as a milestone in the management of prostate cancer and will significantly promote the widespread use of PSMA-PET diagnostics in the coming years.

The investigators now intend to prospectively generate evidence-based data in everyday clinical practice with this so-called Real-World-Evidence (RWE) study. The planned study will enable us to analyze the diagnostic accuracy of Radelumin® in more detail under everyday conditions, whereby dedicated examinations of certain subgroups and the prospective generation of a complete, high-quality database for the future use of artificial intelligence (AI) will be made possible.

Inclusion: > 18 years; Planned [18F]PSMA-1007 PET/CT examination in patients with a first diagnosis of prostate cancer; Informed consent.

Exclusion: Examinations with limited assessability due to technical errors, such as imaging artifacts.

ClinicalTrials.gov NCT06820333