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 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 eligibl

SUBMITTER: Prive BM 

PROVIDER: S-EPMC8566967 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature