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

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• \> 18 years

• Planned \[18F\]PSMA-1007 PET/CT examination in patients with a first diagnosis of prostate cancer

• Informed consent

Locations
Other Locations
Germany
Heinrich Heine University, Medical Faculty, University Hospital Düsseldorf
RECRUITING
Düsseldorf
Contact Information
Primary
Emil Novruzov, Medical Doctor
Emil.Novruzov@med.uni-duesseldorf.de
(+49)211 8118540
Backup
Eduards Mamlins, Medical Doctor
eduards.mamlins@med.uni-duesseldorf.de
(+49)211 8108069
Time Frame
Start Date: 2025-01-10
Estimated Completion Date: 2030-01-31
Participants
Target number of participants: 200
Related Therapeutic Areas
Sponsors
Leads: Heinrich-Heine University, Duesseldorf

This content was sourced from clinicaltrials.gov