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

Trials

Marianne A. Jonker¹  Andries M. Bergman²  Niven Mehra³  Winald R. Gerritsen³  Harm Westdorp³  Daniela E. Oprea-Lager⁴  Wouter V. Vogel⁵  Martin Gotthardt⁶  J. Fred Verzijlbergen⁶  Marcel J. R. Janssen⁶  James Nagarajah⁶  Michel de Groot⁶  Tom W. J. Scheenen⁶  Bastiaan M. Privé⁶  Willemijn A. van Gemert⁶  Patrik Zámecnik⁶  Jelle O. Barentsz⁶  Walter Noordzij⁷  André N. Vis⁸  Henk G. van der Poel⁹  J. Alfred Witjes^1,10  Constantijn H. J. Muselaers^1,10  Inge M. van Oort^1,10 

[1] Department of Health Evidence, Radboudumc;Department of Medical Oncology, NKI Antoni van Leeuwenhoek Hospital;Department of Medical Oncology, Radboudumc;Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center;Department of Radiology and Nuclear Medicine, NKI Antoni van Leeuwenhoek Hospital;Department of Radiology and Nuclear Medicine, Radboudumc;Department of Radiology and Nuclear Medicine, University of Groningen, University Medical Center Groningen;Department of Urology, Amsterdam University Medical Center;Department of Urology, NKI Antoni van Leeuwenhoek Hospital;Department of Urology, Radboudumc;

关键词: Hormone-sensitive prostate cancer;    Lutetium-177-PSMA;    Metastases-directed therapy;    Oligometastases;    Radioligand therapy;    Urologic oncology;   

DOI  :  10.1186/s13063-021-05733-4

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown