EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T

This prospective, single-centre, single-arm phase I/II trial will assess the safety, efficacy and anti-tumour activity of \[161Tb\]Tb-PSMA-I\&T in patients with mCRPC. This study aims to assess and establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended phase 2 dose (RP2D) of \[161Tb\]Tb-PSMA-I\&T in patients with mCRPC. 66 men with mCRPC who have progressed with at least one line of taxane chemotherapy and at least one second-generation androgen receptor (AR)-targeted agent will be enrolled in this trial in two stages: dose escalation and a dose expansion phase.