Diagnostic Performance and Clinical Impact of [18F]PSMA-1007 for Detecting Prostate Cancer Recurrence A Real-World, Prospective Observational Study

What this Trial Is About

Recent advancements have introduced [18F]PSMA-1007 as a new diagnostic tool approved in Europe for prostate cancer management, particularly for patients experiencing biochemical recurrence after initial treatment. This study seeks to evaluate how well this diagnostic method performs and its impact on patient care in everyday clinical settings. By collecting real-world evidence, the research aims to support better management strategies for prostate cancer patients. The study focuses on the use of [18F]PSMA-1007 PET imaging, also known as Radelumin®, which has recently been approved in Germany and other EU countries for primary staging of high-risk prostate cancer and re-staging in cases of biochemical recurrence. This phase 4 observational trial involves routine clinical use of this imaging technique to observe its diagnostic accuracy and effects on patient management. It also plans to create a detailed, high-quality database to support future artificial intelligence applications. Participants will undergo [18F]PSMA-1007 PET imaging as part of their usual clinical care. Researchers will monitor the detection rate of the imaging over six months and assess its clinical impact during the same period. Data collected will help analyze diagnostic performance and influence clinical decisions. The study emphasizes safety and accuracy by excluding cases with technical issues during image acquisition, ensuring reliable results from real-world practice.

Diagnostic Performance of [18F]PSMA-1007 in the Context of Biochemical Recurrence of Prostate Cancer