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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
July 2008
NCT00657904Uploaded 08-14-2014
Available for Download
PDS UID: Prostat_AstraZe_1995_102
A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.
Provider Information
Provider Data Description2.1 Primary objectives The overall primary objectives for the study are: 1. To compare Casodex 150 mg once daily with placebo in terms of time to clinical progression in subjects with non-metastatic prostate cancer. 2. To compare Casodex 150 mg once daily with placebo in terms of overall survival. 2.2 Secondary objectives The overall secondary objectives for the study are: 1. To compare Casodex 150 mg once daily with placebo in terms of time to treatment failure. 2. To investigate the role of serum PSA as a predictor of outcome. 3. To evaluate the tolerability of Casodex 150 mg compared with placebo.
SponsorAstraZeneca
Data ProviderAstraZeneca
Partial set or SubsetOriginal Data
Patients in dataset3618
# of Patients Control1645
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/gh9z-3593
CDISC StandardAZ RDB analysis data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.
ConditionsNon-metastatic Prostate Cancer
Intervention TypeDrug: Bicalutamide
Drug: Placebo
Drug(s)Drug: Bicalutamide
Drug: Placebo
Total Enrolled3618
RandomizationRandomized
Blinding MethodTriple
Arms Intervention1 - Experimental
2 - Placebo Comparator
Secondary ID7054IL/0023
PubMed (PMID)22129214
Collaborator(s)N/A
Region(s)United States
Canada
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLCasodex CSP D6876C00023_Redacted.pdf
CRFSample Case Report Forms 23.pdf
DATA DICTIONARY7054IL_0023 data variables.xlsx
DATA (COMPARATOR ARM)Study 23 Package.zip
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