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

Abstract

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.

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.

TRIAL REGISTRATION

ClinicalTrials.gov NCT04443062 . First posted: June 23, 2020.

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.