EANM procedure guidelines for radionuclide therapy with 177Lu-labelled PSMA-ligands (177Lu-PSMA-RLT)
Prostate-specific membrane antigen (PSMA) is expressed in most prostate cancers and can be identified by PSMA-ligand imaging, which has already become clinically accepted in several countries in- and outside Europe. PSMA-directed radioligand therapy (PSMA-RLT) with Lutetium-177 (177Lu-PSMA) is currently undergoing clinical validation. Retrospective observational data have documented favourable safety and striking clinical responses. Recent results from a prospective clinical trial (phase II) have been published confirming high response rates, low toxicity and reduction of pain in metastatic castration-resistant prostate cancer (mCRPC) patients who had progressed after conventional treatments. Such patients typically survive for periods less than 1.5 years. This has led some facilities to adopt compassionate or unproven use of this therapy, even in the absence of validation within a randomised-controlled trial. As a result, a consistent body of evidence exists to support efficacy and safety data of this treatment. The purpose of this guideline is to assist nuclear medicine specialists to deliver PSMA-RLT as an “unproven intervention in clinical practice”, in accordance with the best currently available knowledge.
KeywordsRadionuclide therapy Prostate cancer Lutetium PSMA Nuclear medicine Theranostics
The guidelines were brought to the attention of the relevant EANM committees and the National Societies of Nuclear Medicine. The comments and suggestions from the EANM committees and the France, United Kingdom, Latvia, and Russian Federation National Societies are highly appreciated and have been considered for this guideline.
Compliance with ethical standards
Conflict of interest
Author C.K. declares that he has no conflict of interest. Author W.P.F. is a consultant for Endocyte and Ipsen and has received personal fees from Radiomedix. Author M.E. reports personal fees from ABX, Blue Earth Diagnostics and Progenics, outside the submitted work, patent application for rhPSMA and is a member of EANM Oncology and Theranostics Committee. Author R.B. is a cofounder and board member of 1717 LSV GmbH, NucleoGenesis GmbH, MTR GmbH, a consultant/advisor to Isotope Technologies Garching GmbH, Endocyte/Novartis, Telix Pharmaceuticals and IPSEN Pharma, and has received research grants from Isotope Technologies Garching GmbH. Author M.F.B. declares that he has no conflict of interest. Author J.C. is a founder and board member of and holds equity in Sofie Biosciences and Trethera Therapeutics, serves on the medical advisory board of Actinium and is a member of the VISION trial steering committee, a clinical trial sponsored by Endocyte. Author R.C.D.B. declares that he has no conflict of interest. Author S.E. declares that he has no conflict of interest. Author F.F. declares that he has no conflict of interest. Author R.J.H. holds stock in Telix Pharmaceuticals on behalf of his institution and is a member of its scientific advisory board. Author T.A.H. has received research grants from Philips and Advanced Accelerator Applications and has served on advisory boards for Ipsen and Curium. Author L.K. declares that he has no conflict of interest. Author M.K. is member of the medical advisory board of NRG and his department receives research grants from AAA. Author K.K. holds patent rights for PSMA-617 and PSMA-1007 and is SAB member of Telix Pharmaceuticals. Author M.L. is a member of the board of the EANM and has received research grants from SIEMENS Healthcare, IPSEN Pharma, Nordic Nanovector and ABX advanced biochemical compounds. Author F.M.M. declares that he has no conflict of interest. Author W.O. has received speaker honoraria and advisory board fees from Bayer. Author K.R. declares that he has no conflict of interest. Author H.S. declares that he has no conflict of interest. Author I.V. declares that she has no conflict of interest. Author H-J.W. owns stock in Scintomics GmbH (Germany) and Scintomics Molecular, Applied Theranostics GmbH (Germany). Author L.B. has served as consultant for AAA and Ipsen and has received a research grant from AAA. Author S.F. declares that he has no conflict of interest. Author U.H. declares that he has no conflict of interest. Author K.H. reports personal fees from Bayer, other from Sofie Biosciences, personal fees from SIRTEX, other from ABX, personal fees from Adacap, personal fees from Curium, personal fees from Endocyte, grants and personal fees from BTG, personal fees from IPSEN, personal fees and non-financial support from Siemens Healthineers and non-financial support from GE Healthcare, outside the submitted work.
This article does not contain any studies with human participants or animals performed by any of the authors.
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