Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

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

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

One/TwoPhase One/Two

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Systemic therapy | Urinary systemProstate

Trial Overview Read MoreRead more

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 cancer.
 

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

This is a systemic therapy trial.

You may be able to join this trial if:

  • 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.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Other Non-Commercial Sponsor

Peter MacCallum Cancer Centre

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).

Recruiting Hospitals Read MoreRead more

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Richelle Linklater
PCCTU.MoncA@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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