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

Background The BULLSEYE trial is a multicenter, open-label, randomized controlled trial to test the hypothesis if .sup.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 .sup.177Lu-PSMA-617 instead of .sup.177Lu-PSMA-I&T and (2) responding patients with residual disease on .sup.18F-PSMA PET after the first two cycles are eligible to receive additional two cycles of 7.4 GBq .sup.177Lu-PSMA in weeks 12 and 18, summing up to a maximum of 4 cycles if indicated. Therefore, patients receiving .sup.177Lu-PSMA-617 will also receive an interim .sup.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 .sup.177Lu-PSMA-I&T under the previous protocol will be replaced. Trial registration ClinicalTrials.gov NCT04443062. First posted: June 23, 2020. Keywords: Hormone-sensitive prostate cancer, Lutetium-177-PSMA, Metastases-directed therapy, Oligometastases, Radioligand therapy, Urologic oncology