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

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

doi:10.1007/s00259-023-06255-8

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

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

^*Corresponding author for this work

Radiology & Nuclear Medicine

Research output: Contribution to journal › Article › Academic › peer-review

166 Citations (Scopus)

39 Downloads (Pure)

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.

Original language	English
Pages (from-to)	2830-2845
Number of pages	16
Journal	European Journal of Nuclear Medicine and Molecular Imaging
Volume	50
Issue number	9
DOIs	https://doi.org/10.1007/s00259-023-06255-8
Publication status	Published - Jul 2023

Bibliographical note

Funding Information:
The guidelines were brought to the attention of the relevant EANM Committees and SNMMI councils/centers-of-excellence, Board of Directors and the National Societies of Nuclear Medicine. The comments and suggestions from the involved EANM and the SNMMI Committees/Councils are highly appreciated and have been considered for this Guideline. We also thank for the contributions for the National Delegates and the SNMMI public review.

Publisher Copyright:
© 2023, The Author(s).

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Joint EANM SNMMI procedure guideline for the use of 177Lu-labeled PSMA-targeted radioligand-therapy (177Lu-PSMA-RLT)Final published version, 792 KBLicence: CC BY

Cite this

Kratochwil, C., Fendler, W. P., Eiber, M., Hofman, M. S., Emmett, L., Calais, J., Osborne, J. R., Iravani, A., Koo, P., Lindenberg, L., Baum, R. P., Bozkurt, M. F., Delgado Bolton, R. C., Ezziddin, S., Forrer, F., Hicks, R. J., Hope, T. A., Kabasakal, L., Konijnenberg, M., ... Hermann, K. (2023). Joint EANM/SNMMI procedure guideline for the use of ¹⁷⁷Lu-labeled PSMA-targeted radioligand-therapy (¹⁷⁷Lu-PSMA-RLT). European Journal of Nuclear Medicine and Molecular Imaging, 50(9), 2830-2845. https://doi.org/10.1007/s00259-023-06255-8

@article{602927e2a5534a07b090c472eb45b373,

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

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.",

author = "Clemens Kratochwil and Fendler, \{Wolfgang P.\} and Matthias Eiber and Hofman, \{Michael S.\} and Louise Emmett and Jeremie Calais and Osborne, \{Joseph R.\} and Amir Iravani and Phillip Koo and Liza Lindenberg and Baum, \{Richard P.\} and Bozkurt, \{Murat Fani\} and \{Delgado Bolton\}, \{Roberto C.\} and Samer Ezziddin and Flavio Forrer and Hicks, \{Rodney J.\} and Hope, \{Thomas A.\} and Levent Kabasakal and Mark Konijnenberg and Klaus Kopka and Michael Lassmann and Mottaghy, \{Felix M.\} and Oyen, \{Wim J.G.\} and Kambiz Rahbar and Heiko Schoder and Irene Virgolini and Lisa Bodei and Stefano Fanti and Uwe Haberkorn and Ken Hermann",

note = "Funding Information: The guidelines were brought to the attention of the relevant EANM Committees and SNMMI councils/centers-of-excellence, Board of Directors and the National Societies of Nuclear Medicine. The comments and suggestions from the involved EANM and the SNMMI Committees/Councils are highly appreciated and have been considered for this Guideline. We also thank for the contributions for the National Delegates and the SNMMI public review. Publisher Copyright: {\textcopyright} 2023, The Author(s).",

year = "2023",

month = jul,

doi = "10.1007/s00259-023-06255-8",

language = "English",

volume = "50",

pages = "2830--2845",

journal = "European Journal of Nuclear Medicine and Molecular Imaging",

issn = "1619-7070",

publisher = "Springer-Verlag",

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Kratochwil, C, Fendler, WP, Eiber, M, Hofman, MS, Emmett, L, Calais, J, Osborne, JR, Iravani, A, Koo, P, Lindenberg, L, Baum, RP, Bozkurt, MF, Delgado Bolton, RC, Ezziddin, S, Forrer, F, Hicks, RJ, Hope, TA, Kabasakal, L, Konijnenberg, M, Kopka, K, Lassmann, M, Mottaghy, FM, Oyen, WJG, Rahbar, K, Schoder, H, Virgolini, I, Bodei, L, Fanti, S, Haberkorn, U & Hermann, K 2023, 'Joint EANM/SNMMI procedure guideline for the use of ¹⁷⁷Lu-labeled PSMA-targeted radioligand-therapy (¹⁷⁷Lu-PSMA-RLT)', European Journal of Nuclear Medicine and Molecular Imaging, vol. 50, no. 9, pp. 2830-2845. https://doi.org/10.1007/s00259-023-06255-8

TY - JOUR

T1 - Joint EANM/SNMMI procedure guideline for the use of 177Lu-labeled PSMA-targeted radioligand-therapy (177Lu-PSMA-RLT)

AU - Kratochwil, Clemens

AU - Fendler, Wolfgang P.

AU - Eiber, Matthias

AU - Hofman, Michael S.

AU - Emmett, Louise

AU - Calais, Jeremie

AU - Osborne, Joseph R.

AU - Iravani, Amir

AU - Koo, Phillip

AU - Lindenberg, Liza

AU - Baum, Richard P.

AU - Bozkurt, Murat Fani

AU - Delgado Bolton, Roberto C.

AU - Ezziddin, Samer

AU - Forrer, Flavio

AU - Hicks, Rodney J.

AU - Hope, Thomas A.

AU - Kabasakal, Levent

AU - Konijnenberg, Mark

AU - Kopka, Klaus

AU - Lassmann, Michael

AU - Mottaghy, Felix M.

AU - Oyen, Wim J.G.

AU - Rahbar, Kambiz

AU - Schoder, Heiko

AU - Virgolini, Irene

AU - Bodei, Lisa

AU - Fanti, Stefano

AU - Haberkorn, Uwe

AU - Hermann, Ken

N1 - Funding Information: The guidelines were brought to the attention of the relevant EANM Committees and SNMMI councils/centers-of-excellence, Board of Directors and the National Societies of Nuclear Medicine. The comments and suggestions from the involved EANM and the SNMMI Committees/Councils are highly appreciated and have been considered for this Guideline. We also thank for the contributions for the National Delegates and the SNMMI public review. Publisher Copyright: © 2023, The Author(s).

PY - 2023/7

Y1 - 2023/7

N2 - 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.

AB - 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.

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DO - 10.1007/s00259-023-06255-8

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