The recent development of dedicated prostate-specific membrane antigen (PSMA) targeted radioligands shows the potential to change and improve the diagnosis and therapy of prostate cancer. There is an increasing number of prospective trials to further establish these tracers in the clinical setting. We analyzed data from the ClinicalTrials.gov registry including all listed prospective trials with PSMA-ligands for prostate cancer as of October 2019 concerning the different tracers and study characteristics. We found n = 104 eligible studies with a total of n = 25 different tracers in use: most frequently [68Ga]Ga-PSMA-11 (32%), followed by [18F]DCFPyL (24%) and [177Lu]Lu-PSMA-617 (10%). 85% are single-center, 15% multi-center studies. 95% national and 5% international studies. 34% are phase-II, 24% phase-I, 13% phase-I/-II, 12% phase-II/-III and phase-III and 7% early-phase-I. The primary purpose was classified as diagnostic in 72% of cases and therapeutic in 23% of cases. Most studies were executed in the USA (70%), followed by Canada (13%) and France (6%). This quantitative descriptive registry analysis indicates the rapid and global clinical developments and current status of PSMA-radioligands with emphasis on radiopharmaceutical and organizational aspects. It will be very interesting to see which tracers will prevail in the clinical setting.
Pharmaceuticals (Basel, Switzerland). 2020 Jan 13*** epublish ***
Claus Zippel, Sarah C Ronski, Sabine Bohnet-Joschko, Frederik L Giesel, Klaus Kopka
Faculty of Management and Economics, Witten/Herdecke University, 58448 Witten, Germany., Praxis für Nuklearmedizin, Klinikum der Stadt Ludwigshafen, 67063 Ludwigshafen am Rhein, Germany., Department of Nuclear Medicine, Heidelberg University Hospital, 69120 Heidelberg, Germany., Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Institute of Radiopharmaceutical Cancer Research, 01328 Dresden, Germany.