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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

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).

Conditions

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

Cancer

Urinary System Cancers Urinary System

Age

People18+

Phase

I/II

Trial Acronym

VIOLET

More information

Trial Identifiers

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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

Eligibility

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.