drugset / Trial / NCT02204943

Pharmacodynamic Study of Radium-223 in Men With Bone Metastatic Castration-Resistant Prostate Cancer

NCT02204943

Phase 0 Completed 20 enrolled Duke University Bayer · collab
NaSingle-groupOpen-labelBasic science

Summary

This study will examine biomarkers involved in osteomimicry in bone metastases and circulating tumor cells (CTCs) of men with mCRPC before and during therapy with the bone-targeting radiopharmaceutical radium-223. This study will also examine the bio-distribution of radium-223 in bone and bone metastases of men with mCRPC. The investigators hypothesize that bone metastases and CTCs in men with mCRPC will commonly express markers of EMT/plasticity and osteomimicry, not just in the normal surrounding osteoblastic stroma but in the epithelial tumor cells themselves and that radium-223 will target both of these compartments including the more mesenchymal/osteoblastic tumor cells and the surrounding osteoblasts in the active bone microenvironment, with a relative sparing of normal bone and bone marrow.

Timeline

Start
2015-05-06
Primary completion
2017-07-31
Completion
2017-07-31

Drugs

EvaluationDrugModalityDoseRoute
Background Radium-223 dichloride Other / unclassified