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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
July 2010
NCT00286091Uploaded 09-26-2016
Available for Download
PDS UID: Prostat_Amgen_2006_155
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
Provider Information
Provider Data DescriptionThe 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.
SponsorAmgen
Data ProviderAmgen
Partial set or SubsetOriginal Data
Patients in dataset1432
# of Patients Control576
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/pejz-gy25
CDISC StandardADS
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.
ConditionsHormone Refractory Prostate Cancer
Intervention TypeBiological: Denosumab
Biological: Placebo
Drug(s)N/A
Total Enrolled1435
RandomizationRandomized
Blinding MethodQuadruple
Arms InterventionPlacebo - Placebo Comparator
Denosumb - Experimental
Secondary IDN/A
PubMed (PMID)22093187
Collaborator(s)N/A
Region(s)N/A
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOL20050147 Protocol Amend 4 REDACTED.pdf
CRFAmgen 20050147 CRF REDACTED.pdf
DATA DICTIONARYAmgen 20050147 DDT.pdf
DATA (COMPARATOR ARM)Amgen 20050147 SAS datasets.zip
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