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

Depending on the study design and definition of the patient population, the detection rate of pelvic lymph nodes in particular using PSMA imaging is reported to be >80%. The results of the studies thus demonstrate a superior diagnostic accuracy compared to previous methods as well as a significant influence of PSMA imaging on the clinical course. Radelumin® was approved on the basis of these promising results from numerous retrospective studies and the prospective, randomized approval study.

Nevertheless, it should be noted that the results derived from such data generally deviate from the data in everyday clinical practice for various reasons. Furthermore, the retrospectively planned studies show multiple general weaknesses, whereby the prospective randomized approval studies also show a priori weaknesses. These result from a very limited observation phase and the lack of long-term data, despite good planning with a high power, a small number of patients and the targeted homogeneity of the patient population. In the context of a real-world evidence study, which focuses on routine clinical care, the above-mentioned disadvantages are compensated for by long-term observation, a considerably larger patient population and a realistic patient mix.