NCT05383079

Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men with Metastatic Castration-Resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (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 of Radium-223 in combination with 177Lu-PSMA-I\&T in metastatic castration-resistant prostate cancer: Phase I/II study

Detailed description

This prospective, single-centre, single-arm, open label, phase I/II trial will assess and establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of Radium-223 in combination with 177Lu-PSMA-I\&T in patients with mCRPC. 36 men with mCRPC who have progressed on second-generation AR antagonist will be enrolled in this trial in two stages: dose escalation and a dose expansion phase over a period of 24 months.

Conditions

• Metastatic Castration-resistant Prostate Cancer
• MCRPC
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Lutetium-177 PSMA-I&T	Patients will be given 7.4 GBq of 177Lu-PSMA every 6 weeks for up to 6 Cycles
DRUG	Radium-223	During dose escalation, doses of Radium-223 that will be administered include 27.5 kBq/kg and 55 kBq/kg. The maximum tolerated dose of Radium-223 will be used during dose expansion. Radium-223 will be given once every 6 weeks for up to 6 doses between day 1-5 of each Cycle.

Timeline

• Start date: 2022-09-13
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2022-05-19
• Last updated: 2025-02-07

Locations

1 site across 1 country: Australia