NCT03874884

177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 1 dose-escalation and dose-expansion study is designed to evaluate the safety and tolerability of olaparib in combination with 177Lutetium-Prostate Specific Membrane Antigen (177 Lu-PSMA) in patients with metastatic castration resistant prostate cancer (mCRPC).

Detailed description

This phase 1, open label, multicentre, dose-escalation and dose-expansion study is designed to evaluate the safety and tolerability of olaparib in combination with 177Lu-PSMA in patients with mCRPC. Patients with mCRPC who have previously progressed on a novel AR targeted agent (abiraterone and/or enzalutamide and/or apalutamide) and have not had prior exposure to platinums, PARP inhibitors or 177Lu-PSMA will be eligible for the study. Patients can have had prior exposure to docetaxel in the chemotherapy naïve setting or castrate setting. Patients will be enrolled in two stages: a dose escalation and a dose expansion phase. The clinical and translational outcomes from this study will inform the design of future phase 2/3 clinical trials of this combination. This is a single arm study where patients will receive 177Lu-PSMA and olaparib for up to 6 cycles.

Conditions

• Metastatic Castration Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
DRUG	Olaparib	During dose escalation doses of olaparib that can be administered are 50mg BD D2-15, 100mg BD D2-15, 150mg BD D2-15, 200mg BD D2-15,250mg BD D2-15, 300mg BD D2-15, 200mg BD D4-14, 300mg BD D-4-14 or 400mg D-4-18 of a 42 day cycle for up to 6 cycles. The recommended phase 2 dose of olaparib will be used in 2 consecutive dose expansion cohorts. The first cohort will received the recommended phase 2 dose of Olaparib on D4-14 of a 42 day cycle. Patients enrolled in the second dose expansion cohort will receive Olaparib continuously from cycle 1 day -4 to cycle 6 day 42.
COMBINATION_PRODUCT	177Lu-PSMA	A fixed 7.4Gbq administered activity of 177Lu-PSMA will be given 6 weekly for up to 6 cycles.

Timeline

• Start date: 2019-07-09
• Primary completion: 2025-05-01
• Completion: 2026-06-01
• First posted: 2019-03-14
• Last updated: 2025-05-14

Locations

2 sites across 1 country: Australia