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
Where in Germany
- Heinrich Heine University, Medical Faculty, University Hospital DüsseldorfDüsseldorf, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.