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.
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.
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.
ClinicalTrials.gov NCT04443062 . First posted: June 23, 2020.
Trials. 2021 Nov 04*** epublish ***
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
Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands., Department of Urology, Radboudumc, Nijmegen, The Netherlands., Department of Health Evidence, Radboudumc, Nijmegen, The Netherlands., Department of Medical Oncology, Radboudumc, Nijmegen, The Netherlands., Department of Radiology and Nuclear Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands., Department of Radiology and Nuclear Medicine, NKI Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands., Department of Medical Oncology, NKI Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands., Department of Urology, NKI Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands., Department of Urology, Amsterdam University Medical Center, Amsterdam, The Netherlands., Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands., Department of Radiology and Nuclear Medicine, Radboudumc, Geert Grooteplein Zuid 10, 6525, GA, Nijmegen, The Netherlands. .