Clinical Trials Logo

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 up to 6 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 June 2026

See also
  Status Clinical Trial Phase
Terminated NCT05208229 - The Role of WB-MRI in the Evaluation of Prostate Cancer Patients Treated With Lutetium - Prostate Specific Membrane Antigen (Lu-PSMA)
Suspended NCT05425862 - Pidnarulex and Talazoparib in Patients With Metastatic Castration Resistant Prostate Cancer Phase 1
Active, not recruiting NCT03480646 - ProSTAR: A Study Evaluating CPI-1205 in Patients With Metastatic Castration Resistant Prostate Cancer Phase 1/Phase 2
Terminated NCT03549000 - A Phase I/Ib Study of NZV930 Alone and in Combination With PDR001 and /or NIR178 in Patients With Advanced Malignancies. Phase 1
Completed NCT05701007 - Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland
Terminated NCT04052204 - Avelumab With Bempegaldesleukin With or Without Talazoparib or Enzalutamide in Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03724747 - Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer Phase 1
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