Radium Ra 223 With Enzalutamide Compared to Enzalutamide Alone in Men With Metastatic Castration Refractory Prostate Cancer

NCT02199197 ↗

Phase 2 Completed 49 enrolled University of Utah

RandomizedParallel-groupOpen-labelTreatment

Summary

Study of Radium Ra 223 dichloride with enzalutamide compared to enzalutamide alone in men with metastatic castration refractory prostate cancer

Timeline

Start: 2014-06-25
Primary completion: 2018-04-19
Completion: 2019-10-03

Outcome

Met primary endpoint

paper Primary endpoint was met. PMID 31937614 ↗

paper A statistically significant relative change to NTP ratios between arms (0.64, 95% confidence interval, 0.51-0.81; P = 0.00048) favored RE versus enzalutamide. PMID 31937614 ↗

Publications

Agarwal N, Nussenzveig R, Hahn AW, Hoffman JM, Morton K, Gupta S, Batten J, Thorley J, Hawks J, Santos VS, Nachaegari G, Wang X, Boucher K, Haaland B, Maughan BL. Prospective Evaluation of Bone Metabolic Markers as Surrogate Markers of Response to Radium-223 Therapy in Metastatic Castration-resistant Prostate Cancer. Clin Cancer Res. 2020 May 1;26(9):2104-2110. doi: 10.1158/1078-0432.CCR-19-2591. Epub 2020 Jan 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Enzalutamide	Other / unclassified	160 mg	Oral
Subject	Radium-223 dichloride	Other / unclassified	55 mbq/kg	Intravenous