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Type(s) of Cancer
Prostate
Study Phase
Phase 3
Study Completion Date
August 2008
NCT00673205Uploaded 08-14-2014
Available for Download
PDS UID: Prostat_AstraZe_1995_105
A Randomized, Double-Blind, Parallel-Group Trial Comparing Bicalutamide (Casodex) 150mg Once Daily With Placebo in Patients With Non-metastatic Prostate Cancer
Provider Information
Provider Data DescriptionPrimary 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 evaluate the tolerability of Casodex 150 mg compared with placebo. 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 overall survival. 2. To compare Casodex 150 mg once daily with placebo in terms of time to treatment failure. 3. To investigate the role of serum PSA as a predictor of outcome.
SponsorAstraZeneca
Data ProviderAstraZeneca
Partial set or SubsetOriginal Data
Patients in dataset3588
# of Patients Control1805
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/dwqy-sd17
CDISC StandardRaw or Case Report Form data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe purpose of this trial is to study the effect of adjuvant or immediate hormonal therapy, versus placebo, in subjects who have either undergone a primary therapy (principally radical prostatectomy or radiotherapy) or who were otherwise to be managed by watchful waiting.
ConditionsNon-Metastatic Prostate Cancer
Intervention TypeDrug: Bicalutamide
Drug: Placebo
Drug(s)Drug: Placebo
Drug: Bicalutamide
Total Enrolled3588
RandomizationRandomized
Blinding MethodTriple
Arms InterventionA - Placebo Comparator
B - Active Comparator
Secondary ID7054IL/0024
PubMed (PMID)22129214
Collaborator(s)N/A
Region(s)Australia
Austria
Belgium
Czech Republic
Germany
Hungary
Ireland
Israel
Italy
Mexico
Netherlands
Poland
Portugal
South Africa
Spain
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLCasodex CSP D6876C00024_Redacted.pdf
CRF7Sample_Case_Report_Forms 24.pdf
DATA DICTIONARY7054IL_0024 data variables.xlsx
DATA (COMPARATOR ARM)Study 24 package.zip
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