Joint EANM/SNMMI procedure guideline for the use of Lu-177-labeled PSMA-targeted radioligand-therapy (Lu-177-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 Delgado C. 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 Lu-177-labeled PSMA-targeted radioligand-therapy (Lu-177-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 Delgado C. Bolton, Samer Ezziddin, Flavio Forrer, Rodney J. Hicks, Thomas A. Hope, Levent Kabasakal, Mark Konijnenberg, Klaus KopkaMichael 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

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

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 [Lu-177]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 Lu-177-PSMA-radioligand therapy (RLT) also has high potential in additional clinical situations. Hence, the radiopharmaceuticals [Lu-177]Lu-PSMA-617 and [Lu-177]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 Lu-177-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 [Lu-177]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
Early online date	1 May 2023
DOIs	https://doi.org/10.1007/s00259-023-06255-8
Publication status	Published - 1 Jul 2023

Keywords

PSMA
EANM
SNMMI
[Lu-177]Lu-PSMA-617
RESISTANT PROSTATE-CANCER
I-AND-T
MEMBRANE ANTIGEN-EXPRESSION
RADIONUCLIDE THERAPY
RADIATION-DOSIMETRY
NORMAL ORGANS
MULTICENTER
SURVIVAL
SAFETY
INTERNALIZATION

Access to Document

10.1007/s00259-023-06255-8Licence: 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., Bolton, R. D. 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 Lu-177-labeled PSMA-targeted radioligand-therapy (Lu-177-PSMA-RLT). European Journal of Nuclear Medicine and Molecular Imaging, 50(9), 2830-2845. https://doi.org/10.1007/s00259-023-06255-8

@article{df28b4eb81144b0eafe08e25e07eb760,

title = "Joint EANM/SNMMI procedure guideline for the use of Lu-177-labeled PSMA-targeted radioligand-therapy (Lu-177-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 [Lu-177]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 Lu-177-PSMA-radioligand therapy (RLT) also has high potential in additional clinical situations. Hence, the radiopharmaceuticals [Lu-177]Lu-PSMA-617 and [Lu-177]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 Lu-177-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 [Lu-177]Lu-PSMA-617 or other emerging ligands on an individual patient basis.",

keywords = "PSMA, EANM, SNMMI, [Lu-177]Lu-PSMA-617, RESISTANT PROSTATE-CANCER, I-AND-T, MEMBRANE ANTIGEN-EXPRESSION, RADIONUCLIDE THERAPY, RADIATION-DOSIMETRY, NORMAL ORGANS, MULTICENTER, SURVIVAL, SAFETY, INTERNALIZATION",

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 Bolton, {Roberto Delgado 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",

year = "2023",

month = jul,

day = "1",

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, Cham",

number = "9",

}

Kratochwil, C, Fendler, WP, Eiber, M, Hofman, MS, Emmett, L, Calais, J, Osborne, JR, Iravani, A, Koo, P, Lindenberg, L, Baum, RP, Bozkurt, MF, Bolton, RDC, 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 Lu-177-labeled PSMA-targeted radioligand-therapy (Lu-177-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

Joint EANM/SNMMI procedure guideline for the use of Lu-177-labeled PSMA-targeted radioligand-therapy (Lu-177-PSMA-RLT). / Kratochwil, Clemens; Fendler, Wolfgang P.; Eiber, Matthias et al.
In: European Journal of Nuclear Medicine and Molecular Imaging, Vol. 50, No. 9, 01.07.2023, p. 2830-2845.

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

TY - JOUR

T1 - Joint EANM/SNMMI procedure guideline for the use of Lu-177-labeled PSMA-targeted radioligand-therapy (Lu-177-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 - Bolton, Roberto Delgado 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

PY - 2023/7/1

Y1 - 2023/7/1

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 [Lu-177]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 Lu-177-PSMA-radioligand therapy (RLT) also has high potential in additional clinical situations. Hence, the radiopharmaceuticals [Lu-177]Lu-PSMA-617 and [Lu-177]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 Lu-177-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 [Lu-177]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 [Lu-177]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 Lu-177-PSMA-radioligand therapy (RLT) also has high potential in additional clinical situations. Hence, the radiopharmaceuticals [Lu-177]Lu-PSMA-617 and [Lu-177]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 Lu-177-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 [Lu-177]Lu-PSMA-617 or other emerging ligands on an individual patient basis.

KW - PSMA

KW - EANM

KW - SNMMI

KW - [Lu-177]Lu-PSMA-617

KW - RESISTANT PROSTATE-CANCER

KW - I-AND-T

KW - MEMBRANE ANTIGEN-EXPRESSION

KW - RADIONUCLIDE THERAPY

KW - RADIATION-DOSIMETRY

KW - NORMAL ORGANS

KW - MULTICENTER

KW - SURVIVAL

KW - SAFETY

KW - INTERNALIZATION

U2 - 10.1007/s00259-023-06255-8

DO - 10.1007/s00259-023-06255-8

M3 - Article

C2 - 37246997

SN - 1619-7070

VL - 50

SP - 2830

EP - 2845

JO - European Journal of Nuclear Medicine and Molecular Imaging

JF - European Journal of Nuclear Medicine and Molecular Imaging

IS - 9

ER -