Impact of [18F] PSMA-1007 Imaging for Primary Staging of Prostate Cancer

Condition(s) studied

Study 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

Primary outcome measure(s)

• Diagnostic Accuracy and Prognostic Value of [18F]PSMA-1007 PET/CT in Primary Staging of Prostate Cancer — Interim analyses will be performed annually, with a final analysis at 5 years.
  1. The primary outcome will assess the diagnostic accuracy of \[18F\]PSMA-1007 PET/CT by comparing its sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) against histopathological confirmation or composite clinical follow-up as the reference standard. 2. The prognostic value will be evaluated by analyzing the association between baseline PSMA PET/CT-derived parameters (e.g., SUVmax, tumor burden, lesion distribution) and oncological outcomes, including biochemical recurrence-free survival and progression-free survival. 3. Quantitative PET parameters will be extracted using a standardized semi-automated segmentation method, and survival analysis will be conducted using Kaplan-Meier estimates and Cox proportional hazards models.

Trial sites (1)

More Heinrich-Heine University, Duesseldorf trials in Germany

Other trials for the same condition