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Prostate

D 6876C00024: A Randomised, Double-blind, Parallel-group Trial Comparing Casodex TM 150 mg Once Daily With Placebo In Subjects With Non-metastatic Prostate Cancer

Unique Data Set IDProstat_AstraZe_1995_105
DownloadableYes
SponsorAstraZenecaData ProviderAstraZenecaTotal Study Enrolled Patients3588Comparator (Control) Arm Enrolled Patients1805RandomizationYesClinicalTrial.gov IDN/AClinicalTrial.gov URLN/A
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeOther

Clinical Trial Title

D 6876C00024: A Randomised, Double-blind, Parallel-group Trial Comparing Casodex TM 150 mg Once Daily With Placebo In Subjects With Non-metastatic Prostate Cancer

Trial Summary and Conditions

The 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. Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment

Data Summary

All data vcollected from placebo arm

Study Objectives

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 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.

Outcome Measures

Primary Outcome Measures: ?Time to clinical progression ?Tolerability in terms of adverse events and laboratory parameters Secondary Outcome Measures: ?Survival ?Time to treatment failure ?Prostate-specific antigen

Available Downloads:

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

PROTOCOL: Casodex CSP D6876C00024_Redacted.pdf

CRF: 7Sample_Case_Report_Forms 24.pdf

DATA DICTIONARY: 7054IL_0024 data variables.xlsx

DATA (COMPARATOR ARM): Study 24 package.zip