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Clinical Trial 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).


Clinical Trial 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 upto 4 cycles. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03874884
Study type Interventional
Source Peter MacCallum Cancer Centre, Australia
Contact Shahneen Sandhu
Phone +61 3 8559 7902
Email Shahneen.Sandhu@petermac.org
Status Recruiting
Phase Phase 1
Start date July 9, 2019
Completion date December 2023

See also
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Completed NCT04516161 - EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)
Withdrawn NCT02130947 - Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide N/A