Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer
Recruiting · NCT06820333 · Observational (researchers observe without assigning treatment) · Lead sponsor: Heinrich-Heine University, Duesseldorf
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- \> 18 years
- Planned \[18F\]PSMA-1007 PET/CT examination in patients with a first diagnosis of prostate cancer
- Informed consent
Exclusion criteria
- \- Examinations with limited assessability due to technical errors, such as imaging artifacts.
Where it is running
1 location listed.
- Heinrich Heine University, Medical Faculty, University Hospital Düsseldorf - Düsseldorf, North Rhine-Westphalia, Germany