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Prostate

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer

Unique Data Set IDProstat_Amgen_2006_155
DownloadableYes
SponsorAmgenData ProviderAmgenTotal Study Enrolled Patients1432Comparator (Control) Arm Enrolled Patients576RandomizationYesClinicalTrial.gov IDNCT00286091ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00286091?term=20050147&rank=2
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypePlaceboData Set TypeADS

Clinical Trial Title

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab on Prolonging Bone Metastasis-Free Survival in Men with Hormone-Refractory Prostate Cancer

Trial Summary and Conditions

This is an international, phase 3, randomized, double-blind, placebo-controlled study in subjects with castrate-resistant prostate cancer. Subjects were randomized in a 1:1 ratio to receive 120 mg denosumab or placebo SC Q4W. The randomization schedule was stratified based on PSA criteria (PSA level "d 8.0 ng/mL AND PSA doubling time "T 10.0 months [yes/no]) and previous or current chemotherapy for prostate cancer (yes/no). Subjects enrolled in the study received investigational product Q4W in a blinded manner until the results of the efficacy and safety analyses were completed (ie, until the end of the extended blinded treatment phase).

Data Summary

Control arm data including demographics, disease characteristics, safety and efficacy

Study Objectives

The primary objective of this study was to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone-refractory (ie, castrate-resistant) prostate cancer who have no bone metastasis at baseline. The secondary objectives were to compare the treatment effect of denosumab with placebo on the time to first bone metastasis (excluding deaths) and overall survival, and to assess the safety and tolerability of denosumab compared with placebo. The exploratory objectives were to evaluate the treatment effect of denosumab compared with placebo on prostate cancer progression at any site, prostate cancer progression-free survival, change in PSA level, fractures, healthcare utilization and change in patient-reported outcomes (PRO), change in bone turnover markers, and to assess serum trough levels of denosumab.

Outcome Measures

The primary objective of this study was to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone-refractory (ie, castrate-resistant) prostate cancer who have no bone metastasis at baseline. The secondary objectives were to compare the treatment effect of denosumab with placebo on the time to first bone metastasis (excluding deaths) and overall survival, and to assess the safety and tolerability of denosumab compared with placebo. The exploratory objectives were to evaluate the treatment effect of denosumab compared with placebo on prostate cancer progression at any site, prostate cancer progression-free survival, change in PSA level, fractures, healthcare utilization and change in patient-reported outcomes (PRO), change in bone turnover markers, and to assess serum trough levels of denosumab.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: 20050147 Protocol Amend 4 REDACTED.pdf

CRF: Amgen 20050147 CRF REDACTED.pdf

DATA DICTIONARY: Amgen 20050147 DDT.pdf

DATA (COMPARATOR ARM): Amgen 20050147 SAS datasets.zip