Prostate-Specific Antigen Kinetics and Outcomes in Patients with Bone Metastases from Castration-Resistant Prostate Cancer Treated with or Without Zoledronic.

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Prostate-Specific Antigen Kinetics and Outcomes in Patients with Bone Metastases from Castration-Resistant Prostate Cancer Treated with or Without Zoledronic Acid  Fred Saad, Scott Segal, James Eastham  European Urology  Volume 65, Issue 1, Pages 146-153 (January 2014) DOI: 10.1016/j.eururo.2012.05.007 Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 1 Trial registration and Consolidated Standards of Reporting Trials (CONSORT) information. The phase 3 trial has no trial registry name, number, or URL. Patient enrollment and study treatment took place between June 1998 and January 2001. Results for the phase 3 trial were published in 2002 [11] and 2004 [10]. The CONSORT diagram was originally published in 2004 [10]. * Three patients, one randomly assigned to receive zoledronic acid 4mg and two randomly assigned to receive zoledronic acid at 8/4mg, never received the study drug and were not included in the safety analysis. One patient randomly assigned to receive zoledronic acid at 8/4mg incorrectly received 4mg; this patient was included in the 8/4-mg group for efficacy and in the 4-mg group for safety analysis. European Urology 2014 65, 146-153DOI: (10.1016/j.eururo.2012.05.007) Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 2 Kaplan-Meier estimates for overall survival by baseline prostate-specific antigen (PSA) in (A) the placebo group and (B) the zoledronic acid group. Median PSA level (77.3 ng/ml) was used as the high/low cut-off point. CI=confidence interval; RR=relative risk. European Urology 2014 65, 146-153DOI: (10.1016/j.eururo.2012.05.007) Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 3 Cumulative incidence functions for bone disease progression (BDP) by baseline prostate-specific antigen (PSA) in (A) the placebo group and (B) the zoledronic acid group. Median PSA level (77.3 ng/ml) was used as the high/low cut-off point. CI=confidence interval; RR=relative risk. European Urology 2014 65, 146-153DOI: (10.1016/j.eururo.2012.05.007) Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 4 Cumulative incidence functions for skeletal-related events (SREs) by baseline prostate-specific antigen (PSA) in (A) the placebo group and (B) the zoledronic acid group. Median PSA level (77.3 ng/ml) was used as the high/low cut-off point. CI=confidence interval; RR=relative risk. European Urology 2014 65, 146-153DOI: (10.1016/j.eururo.2012.05.007) Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 5 Change in prostate-specific antigen (PSA) levels versus baseline. ZOL=zoledronic acid. European Urology 2014 65, 146-153DOI: (10.1016/j.eururo.2012.05.007) Copyright © 2012 European Association of Urology Terms and Conditions

Fig. 6 Forest plot of relative risks for survival, bone disease progression (BDP), and first skeletal-related event (SRE) in correlative analyses between time-dependent prostate-specific antigen (PSA) levels and clinical outcomes. ZOL=zoledronic acid. European Urology 2014 65, 146-153DOI: (10.1016/j.eururo.2012.05.007) Copyright © 2012 European Association of Urology Terms and Conditions