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Clinical Trial Summary

This clinical trial will evaluate the safety of Cabazitaxel in combination with 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer.


Clinical Trial Description

This prospective, single-centre, single-arm, open label, phase I/II trial will assess the safety, efficacy and anti-tumour activity of cabazitaxel in combination with 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC). This study aims to assess and establish the maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase 2 dose (RP2D) of cabazitaxel in combination with 177Lu-PSMA-617 in patients with mCRPC. 32-44 men with mCRPC who have progressed on prior docetaxel and a second-generation AR antagonist will be enrolled in this trial in two stages: dose escalation and a dose expansion phase over a period of 18 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05340374
Study type Interventional
Source Peter MacCallum Cancer Centre, Australia
Contact Gaurav Sharma
Phone 03 85596830
Email Gaurav.Sharma@petermac.org
Status Recruiting
Phase Phase 1/Phase 2
Start date July 14, 2022
Completion date December 2026

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