NCT05340374

Cabazitaxel in Combination With 177Lu-PSMA-617 in Metastatic Castration-resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• 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 Cabazitaxel in combination with 177Lu-PSMA-617 in metastatic castration-resistant prostate cancer.

Detailed 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.

Conditions

• Metastatic Castration-resistant Prostate Cancer
• mCRPC

Interventions

Type	Name	Description
DRUG	Cabazitaxel	Cabazitaxel belongs to the Taxane group of drugs which function by interfering with microtubule depolymerisation and thus inhibit mitosis, which leads to cell death via apoptosis. It is the first chemotherapy agent to improve survival in patients with mCRPC with progressive disease after docetaxel-based treatment.
DRUG	177Lu-PSMA-617	Lutetium-177 (177Lu)-PSMA is a radiopharmaceutical comprised of a small molecule inhibitor of PSMA that binds with high affinity to PSMA which is expressed on the prostate cancer cell, labelled with 177Lu. 177Lu has favourable characteristics for radionuclide therapy emitting both a short-range (1-2mm) cytotoxic beta-particle, minimising irradiation of non-targeted normal tissues, alongside gamma emission that allows imaging. Multiple clinical trials have demonstrated high clinical activity and limited normal tissue toxicity using 177Lu-PSMA-617.

Timeline

• Start date: 2022-07-14
• Primary completion: 2026-06-20
• Completion: 2026-12-01
• First posted: 2022-04-22
• Last updated: 2025-04-06

Locations

2 sites across 1 country: Australia