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

NCT05521412 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-04-06

No results posted yet for this study

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).

Conditions

Interventions

DRUG

[ 161 Tb]Tb PSMA I&T

During dose escalation, doses of \[161 Tb\]Tb PSMA I\&T will range between 4.4 GBq to 9.5 GBq. The recommended phase 2 dose of \[161 Tb\]Tb PSMA I\&T will be used during dose expansion. \[161Tb\]Tb-PSMA-I\&T dose will be reduced by 0.4 GBq for each subsequent cycles (2 to 6).

Sponsors & Collaborators

  • Peter MacCallum Cancer Centre, Australia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-29
Primary Completion
2025-08-03
Completion
2026-12-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05521412 on ClinicalTrials.gov