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RecruitingLast updated: 15 August 2023

VIOLET: This phase I/II study is evaluating how safe and effective treatment with [161 Tb]Tb PSMA I&T is in men with metastatic castration-resistant prostate cancerEValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T: Phase I/II Study

Clinical summary


This study has two phases: dose escalation and dose expansion. In the dose escalation phase, eligible participants will receive doses of [161 Tb]Tb PSMA I&T on Day 1 of every 6 week Cycle. The dose of [161 Tb]Tb PSMA I&T will vary, and will range between 4.4 GBq to 7.4 GBq. The recommended phase 2 dose (RP2D) of {161 Tb]Tb PSMA I&T will be used in the second phase, dose expansion. [161 Tb]Tb PSMA I&T dose will be reduced by 0.4 GBq for each subsequent cycle (2 to 6).


This trial is treating patients with metastatic castration-resistant prostate cancer.


Urinary System Cancers Urinary System





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Commercial Sponsor

Peter MacCallum Cancer Centre

Scientific Title

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



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