RecruitingPhase 1Phase 2NCT05521412

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

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


Sponsor

Peter MacCallum Cancer Centre, Australia

Enrollment

66 participants

Start Date

Sep 29, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial will evaluate the safety and efficacy of \[161Tb\]Tb -PSMA-I\&T in men with metastatic castration-resistant prostate cancer (mCRPC).


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a type of targeted radiation therapy called radioligand therapy (RLT) — a treatment that delivers radiation directly to prostate cancer cells using a molecule that attaches to a protein called PSMA — in men with advanced prostate cancer that has stopped responding to hormone therapy. **You may be eligible if...** - You are a male 18 years or older - You have prostate cancer confirmed by biopsy or imaging - Your cancer is metastatic and castration-resistant (has spread and no longer responds to hormone therapy) - You have already received at least one taxane chemotherapy and one hormone-blocking drug (unless medically unsuitable) - Your cancer is still progressing (rising PSA, new bone lesions, or tumor growth) - Your PSMA expression on imaging is significant - Your testosterone levels are very low (castration levels) **You may NOT be eligible if...** - You have not had prior hormone-blocking therapy - You do not have significant PSMA expression on a scan - Your overall health is too poor (ECOG >2) - Your cancer is progressing in ways that don't meet study criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[ 161 Tb]Tb PSMA I&T

\[161Tb\]Tb PSMA I\&T commencing as specified for cycle 1, with administered activity reduced by 0.4 GBq for each cycle (2 to 6). The first 3 patients of each dose level or modified schedule of treatment will be subject to safety review prior to dose expansion phase.


Locations(1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

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NCT05521412


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