Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer: the BULLSEYE trial

Abstract Background The BULLSEYE trial is a multicenter, open-label, randomized controlled trial to test the hypothesis if 177Lu-PSMA is an effective treatment in oligometastatic hormone-sensitive prostate cancer (oHSPC) to prolong the progression-free survival (PFS) and postpone the need for androg...

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Autores principales:	Bastiaan M. Privé, Marcel J. R. Janssen, Inge M. van Oort, Constantijn H. J. Muselaers, Marianne A. Jonker, Willemijn A. van Gemert, Michel de Groot, Harm Westdorp, Niven Mehra, J. Fred Verzijlbergen, Tom W. J. Scheenen, Patrik Zámecnik, Jelle O. Barentsz, Martin Gotthardt, Walter Noordzij, Wouter V. Vogel, Andries M. Bergman, Henk G. van der Poel, André N. Vis, Daniela E. Oprea-Lager, Winald R. Gerritsen, J. Alfred Witjes, James Nagarajah
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Hormone-sensitive prostate cancer Lutetium-177-PSMA Metastases-directed therapy Oligometastases Radioligand therapy Urologic oncology Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/d0eae2f7bc184b94b9f6863ede0c30e8
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spelling	oai:doaj.org-article:d0eae2f7bc184b94b9f6863ede0c30e82021-11-08T11:02:50ZUpdate to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer: the BULLSEYE trial10.1186/s13063-021-05733-41745-6215https://doaj.org/article/d0eae2f7bc184b94b9f6863ede0c30e82021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05733-4https://doaj.org/toc/1745-6215Abstract Background The BULLSEYE trial is a multicenter, open-label, randomized controlled trial to test the hypothesis if 177Lu-PSMA is an effective treatment in oligometastatic hormone-sensitive prostate cancer (oHSPC) to prolong the progression-free survival (PFS) and postpone the need for androgen deprivation therapy (ADT). The original study protocol was published in 2020. Here, we report amendments that have been made to the study protocol since the commencement of the trial. Changes in methods and materials Two important changes were made to the original protocol: (1) the study will now use 177Lu-PSMA-617 instead of 177Lu-PSMA-I&T and (2) responding patients with residual disease on 18F-PSMA PET after the first two cycles are eligible to receive additional two cycles of 7.4 GBq 177Lu-PSMA in weeks 12 and 18, summing up to a maximum of 4 cycles if indicated. Therefore, patients receiving 177Lu-PSMA-617 will also receive an interim 18F-PSMA PET scan in week 4 after cycle 2. The title of this study was modified to; “Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer” and is now partly supported by Advanced Accelerator Applications, a Novartis Company. Conclusions We present an update of the original study protocol prior to the completion of the study. Treatment arm patients that were included and received 177Lu-PSMA-I&T under the previous protocol will be replaced. Trial registration ClinicalTrials.gov NCT04443062 . First posted: June 23, 2020.Bastiaan M. PrivéMarcel J. R. JanssenInge M. van OortConstantijn H. J. MuselaersMarianne A. JonkerWillemijn A. van GemertMichel de GrootHarm WestdorpNiven MehraJ. Fred VerzijlbergenTom W. J. ScheenenPatrik ZámecnikJelle O. BarentszMartin GotthardtWalter NoordzijWouter V. VogelAndries M. BergmanHenk G. van der PoelAndré N. VisDaniela E. Oprea-LagerWinald R. GerritsenJ. Alfred WitjesJames NagarajahBMCarticleHormone-sensitive prostate cancerLutetium-177-PSMAMetastases-directed therapyOligometastasesRadioligand therapyUrologic oncologyMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-4 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Hormone-sensitive prostate cancer Lutetium-177-PSMA Metastases-directed therapy Oligometastases Radioligand therapy Urologic oncology Medicine (General) R5-920
spellingShingle	Hormone-sensitive prostate cancer Lutetium-177-PSMA Metastases-directed therapy Oligometastases Radioligand therapy Urologic oncology Medicine (General) R5-920 Bastiaan M. Privé Marcel J. R. Janssen Inge M. van Oort Constantijn H. J. Muselaers Marianne A. Jonker Willemijn A. van Gemert Michel de Groot Harm Westdorp Niven Mehra J. Fred Verzijlbergen Tom W. J. Scheenen Patrik Zámecnik Jelle O. Barentsz Martin Gotthardt Walter Noordzij Wouter V. Vogel Andries M. Bergman Henk G. van der Poel André N. Vis Daniela E. Oprea-Lager Winald R. Gerritsen J. Alfred Witjes James Nagarajah Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer: the BULLSEYE trial
description	Abstract Background The BULLSEYE trial is a multicenter, open-label, randomized controlled trial to test the hypothesis if 177Lu-PSMA is an effective treatment in oligometastatic hormone-sensitive prostate cancer (oHSPC) to prolong the progression-free survival (PFS) and postpone the need for androgen deprivation therapy (ADT). The original study protocol was published in 2020. Here, we report amendments that have been made to the study protocol since the commencement of the trial. Changes in methods and materials Two important changes were made to the original protocol: (1) the study will now use 177Lu-PSMA-617 instead of 177Lu-PSMA-I&T and (2) responding patients with residual disease on 18F-PSMA PET after the first two cycles are eligible to receive additional two cycles of 7.4 GBq 177Lu-PSMA in weeks 12 and 18, summing up to a maximum of 4 cycles if indicated. Therefore, patients receiving 177Lu-PSMA-617 will also receive an interim 18F-PSMA PET scan in week 4 after cycle 2. The title of this study was modified to; “Lutetium-177-PSMA in Oligo-metastatic Hormone Sensitive Prostate Cancer” and is now partly supported by Advanced Accelerator Applications, a Novartis Company. Conclusions We present an update of the original study protocol prior to the completion of the study. Treatment arm patients that were included and received 177Lu-PSMA-I&T under the previous protocol will be replaced. Trial registration ClinicalTrials.gov NCT04443062 . First posted: June 23, 2020.
format	article
author	Bastiaan M. Privé Marcel J. R. Janssen Inge M. van Oort Constantijn H. J. Muselaers Marianne A. Jonker Willemijn A. van Gemert Michel de Groot Harm Westdorp Niven Mehra J. Fred Verzijlbergen Tom W. J. Scheenen Patrik Zámecnik Jelle O. Barentsz Martin Gotthardt Walter Noordzij Wouter V. Vogel Andries M. Bergman Henk G. van der Poel André N. Vis Daniela E. Oprea-Lager Winald R. Gerritsen J. Alfred Witjes James Nagarajah
author_facet	Bastiaan M. Privé Marcel J. R. Janssen Inge M. van Oort Constantijn H. J. Muselaers Marianne A. Jonker Willemijn A. van Gemert Michel de Groot Harm Westdorp Niven Mehra J. Fred Verzijlbergen Tom W. J. Scheenen Patrik Zámecnik Jelle O. Barentsz Martin Gotthardt Walter Noordzij Wouter V. Vogel Andries M. Bergman Henk G. van der Poel André N. Vis Daniela E. Oprea-Lager Winald R. Gerritsen J. Alfred Witjes James Nagarajah
author_sort	Bastiaan M. Privé
title	Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer: the BULLSEYE trial
title_short	Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer: the BULLSEYE trial
title_full	Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer: the BULLSEYE trial
title_fullStr	Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer: the BULLSEYE trial
title_full_unstemmed	Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer: the BULLSEYE trial
title_sort	update to a randomized controlled trial of lutetium-177-psma in oligo-metastatic hormone-sensitive prostate cancer: the bullseye trial
publisher	BMC
publishDate	2021
url	https://doaj.org/article/d0eae2f7bc184b94b9f6863ede0c30e8
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Update to a randomized controlled trial of lutetium-177-PSMA in Oligo-metastatic hormone-sensitive prostate cancer: the BULLSEYE trial

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