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. 2023 Jul;50(9):2830-2845.
doi: 10.1007/s00259-023-06255-8. Epub 2023 May 29.

Joint EANM/SNMMI procedure guideline for the use of 177Lu-labeled PSMA-targeted radioligand-therapy (177Lu-PSMA-RLT)

Clemens Kratochwil  1 , Wolfgang P Fendler  2 , Matthias Eiber  3 , Michael S Hofman  4   5 , Louise Emmett  6 , Jeremie Calais  7 , Joseph R Osborne  8 , Amir Iravani  9 , Phillip Koo  10 , Liza Lindenberg  11   12 , Richard P Baum  13 , Murat Fani Bozkurt  14 , Roberto C Delgado Bolton  15 , Samer Ezziddin  16 , Flavio Forrer  17 , Rodney J Hicks  18 , Thomas A Hope  19 , Levent Kabasakal  20 , Mark Konijnenberg  21 , Klaus Kopka  22   23   24 , Michael Lassmann  25 , Felix M Mottaghy  26   27 , Wim J G Oyen  28   29   30 , Kambiz Rahbar  31 , Heiko Schoder  32 , Irene Virgolini  33 , Lisa Bodei  32 , Stefano Fanti  34 , Uwe Haberkorn  35 , Ken Hermann  2
Affiliations

Joint EANM/SNMMI procedure guideline for the use of 177Lu-labeled PSMA-targeted radioligand-therapy (177Lu-PSMA-RLT)

Clemens Kratochwil et al. Eur J Nucl Med Mol Imaging. 2023 Jul.

Abstract

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.

Keywords: EANM/SNMMI; PSMA; [177Lu]Lu-PSMA-617.

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Conflict of interest statement

C. Kratochwil is a coinventor of PSMA-617 and worked as a scientific consultant for AAA/Novartis, Roche, AdvanCell, Telix. R.J. Hicks is a shareholder of Telix Pharmaceuticals and Founder and Director of PreMIT Pty Ltd. W.J.G. Oyen received speaker fees from Astellas and did advisory boards for AAA/Novartis and Debiopharm. M. Hofman acknowledged philanthropic/government grant support from the Prostate Cancer Foundation (PCF) funded by CANICA Oslo Norway, Peter MacCallum Foundation, Medical Research Future Fund, NHMRC Investigator Grant, Movember, U.S. Department of Defense and the Prostate Cancer Foundation of Australia (PCFA); he received grant support from AAA/Novartis, ANSTO, Bayer, Isotopia, and consulting fees for lectures or advisory boards from Astellas, AstraZeneca, Janssen, Merck/MSD, Mundipharma, and Point Biopharma. K. Kopka is a coinventor of PSMA-617, PSMA-914, and PSMA-1007 and a member of the Scientific Advisory Board of Telix Pharmaceuticals. U. Haberkorn is a coinventor of PSMA-617. W. P. Fendler reports fees from SOFIE Bioscience (research funding), Janssen (consultant, speakers bureau), Calyx (consultant), Bayer (consultant, speakers bureau, research funding), Parexel (image review), Novartis (speakers bureau), and Telix (speakers bureau). M. Eiber reports fees from Blue Earth Diagnostics Ltd. (consultant, research funding), Novartis/AAA (consultant, speaker), Telix (consultant), Bayer (consultant, research funding), RayzeBio (consultant), Point Biopharma (consultant), Eckert-Ziegler (speaker) and Janssen Pharmaceuticals (consultant, speakers bureau), Parexel (image review) and Bioclinica (image review) outside the submitted work and a patent application for rhPSMA. K. Hermann reports personal fees from Bayer, personal fees and other from Sofie Biosciences, personal fees from SIRTEX, non-financial support from ABX, personal fees from Adacap, personal fees from Curium, personal fees from Endocyte, grants and personal fees from Boston Scientific, personal fees from IPSEN, personal fees from Siemens Healthineers, personal fees from GE Healthcare, personal fees from Amgen, personal fees from Novartis, personal fees from ymabs, personal fees from Aktis Oncology, personal fees from Pharma15, personal fees from Theragnostics Ltd., personal fees from Janssen, personal fees from Telix, personal fees from Debiopharm, personal fees from Bain Capital, and personal fees from Eco1R all outside the submitted work. The other authors declared no personal conflict of interest in the field.

References

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