Prostate-specific membrane antigen (PSMA) is expressed by the majority of clinically significant prostate adenocarcinomas, and patients with target-positive disease can easily be identified by PSMA PET imaging. Promising results with PSMA-targeted radiopharmaceutical therapy have already been obtained in early-phase studies using various combinations of targeting molecules and radiolabels. Definitive evidence of the safety and efficacy of [177Lu]Lu-PSMA-617 in combination with standard-of-care has been demonstrated in patients with metastatic castration-resistant prostate cancer, whose disease had progressed after or during at least one taxane regimen and at least one novel androgen-axis drug. Preliminary data suggest that 177Lu-PSMA-radioligand therapy (RLT) also has high potential in additional clinical situations. Hence, the radiopharmaceuticals [177Lu]Lu-PSMA-617 and [177Lu]Lu-PSMA-I&T are currently being evaluated in ongoing phase 3 trials. The purpose of this guideline is to assist nuclear medicine personnel, to select patients with highest potential to benefit from 177Lu-PSMA-RLT, to perform the procedure in accordance with current best practice, and to prepare for possible side effects and their clinical management. We also provide expert advice, to identify those clinical situations which may justify the off-label use of [177Lu]Lu-PSMA-617 or other emerging ligands on an individual patient basis.
European journal of nuclear medicine and molecular imaging. 2023 May 29 [Epub ahead of print]
Clemens Kratochwil, Wolfgang P Fendler, Matthias Eiber, Michael S Hofman, Louise Emmett, Jeremie Calais, Joseph R Osborne, Amir Iravani, Phillip Koo, Liza Lindenberg, Richard P Baum, Murat Fani Bozkurt, Roberto C Delgado Bolton, Samer Ezziddin, Flavio Forrer, Rodney J Hicks, Thomas A Hope, Levent Kabasakal, Mark Konijnenberg, Klaus Kopka, Michael Lassmann, Felix M Mottaghy, Wim J G Oyen, Kambiz Rahbar, Heiko Schoder, Irene Virgolini, Lisa Bodei, Stefano Fanti, Uwe Haberkorn, Ken Hermann
Department of Nuclear Medicine, University Hospital Heidelberg, Heidelberg, Germany. ., Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK)-University Hospital Essen, 45147, Essen, Germany., Department of Nuclear Medicine, Klinikum Rechts Der Isar, Technical University Munich (TUM), 81675, Munich, Germany., Prostate Cancer Theranostics and Imaging Centre of Excellence, Molecular Imaging and Therapeutic Nuclear Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia., Department of Theranostics and Nuclear Medicine, St Vincent's Hospital Sydney, Darlinghurst, Australia., Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, David Geffen School of Medicine at UCLA, University of California Los Angeles, Los Angeles, CA, USA., Department of Radiology, Weill Cornell Medicine, New York, NY, 10021, USA., Department of Radiology, University of Washington School of Medicine, Seattle, WA, USA., Division of Diagnostic Imaging, Banner MD Anderson Cancer Center, Gilbert, AZ, USA., Molecular Imaging Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA., Curanosticum Wiesbaden-Frankfurt, Center for Advanced Radiomolecular Precision Oncology, Wiesbaden, Germany., Hacettepe University Faculty of Medicine, Department of Nuclear Medicine, Ankara, Turkey., Department of Diagnostic Imaging (Radiology) and Nuclear Medicine, University Hospital San Pedro and Centre for Biomedical Research of La Rioja (CIBIR), Logroño (La Rioja), Spain., Department of Nuclear Medicine, Saarland University Medical Center, Homburg, Germany., Department of Radiology and Nuclear Medicine, Kantonsspital St. Gallen, St. Gallen, Switzerland., The University of Melbourne Department of Medicine, St Vincent's Hospital, Melbourne, Australia., Department of Radiology and Biomedical Imaging / Helen Diller Family Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA, USA., Department of Nuclear Medicine, Cerrahpasa Medical Faculty, Istanbul University- Cerrahpasa, Istanbul, Turkey., Radiology & Nuclear Medicine Department, Erasmus MC, Rotterdam, The Netherlands., Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Institute of Radiopharmaceutical Cancer Research, Dresden, Germany., Department of Nuclear Medicine, University Hospital Würzburg, Würzburg, Germany., Department of Nuclear Medicine, RWTH Aachen University Medical Faculty, Aachen, Germany., Department of Biomedical Sciences, Humanitas University, and Humanitas Clinical and Research Centre, Department of Nuclear Medicine, Milan, Italy., Department of Nuclear Medicine, University Hospital Muenster, Muenster, Germany., Department of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA., Department of Nuclear Medicine, Medical University Innsbruck, Innsbruck, Austria., Division of Nuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Bologna, Italy., Department of Nuclear Medicine, University Hospital Heidelberg, Heidelberg, Germany.