Volume 63, Issue 2, Pages (February 2013)

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Volume 63, Issue 2, Pages 189-197 (February 2013) A Randomized, Double-Blind, Dose-Finding, Multicenter, Phase 2 Study of Radium Chloride (Ra 223) in Patients with Bone Metastases and Castration-Resistant Prostate Cancer Christopher C. Parker, Sarah Pascoe, Aleš Chodacki, Joe M. O'Sullivan, Josep R. Germá, Charles Gillies O’Bryan-Tear, Trond Haider, Peter Hoskin European Urology Volume 63, Issue 2, Pages 189-197 (February 2013) DOI: 10.1016/j.eururo.2012.09.008 Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 1 Study design. PSA=prostate-specific antigen; SRE=skeletal-related event; D=day; W=week; M=month. European Urology 2013 63, 189-197DOI: (10.1016/j.eururo.2012.09.008) Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 2 Disposition of all randomized patients (Consolidated Standards of Reporting Trials diagram). European Urology 2013 63, 189-197DOI: (10.1016/j.eururo.2012.09.008) Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 3 Median relative change from baseline in (A) prostate-specific antigen (PSA) and (B) bone alkaline phosphatase (ALP) for the per-protocol population. Arrows indicate the timing of each radium chloride Ra 223 injection. W=week. European Urology 2013 63, 189-197DOI: (10.1016/j.eururo.2012.09.008) Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 4 Percentage of pain responders (pain index score ≤4) by dose group for patients with pain at baseline (per-protocol population). European Urology 2013 63, 189-197DOI: (10.1016/j.eururo.2012.09.008) Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 5 Median hematologic values over time by dose group for (A) white blood cells, (B) neutrophils, (C) lymphocytes, (D) platelets, and (E) hemoglobin. The dotted line represents the value of grade 2 and 3 Common Terminology Criteria for Adverse Events. B=baseline; W=week; M=month. European Urology 2013 63, 189-197DOI: (10.1016/j.eururo.2012.09.008) Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 6 Overall survival of patients receiving three injections of radium chloride Ra 223 at doses of 25, 50, or 80 kBq/kg (safety population); p=0.44 (log-rank) between groups for time to death. European Urology 2013 63, 189-197DOI: (10.1016/j.eururo.2012.09.008) Copyright © 2012 European Association of Urology Terms and Conditions