NCT05521412

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This prospective, single-centre, single-arm phase I/II trial will assess the safety, efficacy and anti-tumour activity of \[161Tb\]Tb-PSMA-I\&T in patients with mCRPC. This study aims to assess and establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs) and recommended phase 2 dose (RP2D) of \[161Tb\]Tb-PSMA-I\&T in patients with mCRPC. 42 men with mCRPC who have progressed with at least one line of taxane chemotherapy and at least one second-generation androgen receptor (AR)-targeted agent will be enrolled in this trial in two stages: dose escalation and a dose expansion phase over a period of 24 months.

Conditions

• Prostate Cancer
• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2022-09-29
• Primary completion: 2025-08-03
• Completion: 2026-12-01
• First posted: 2022-08-30
• Last updated: 2025-04-06

Locations

1 site across 1 country: Australia