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Prostate

D6876C00023: A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex TM) Versus Placebo in Patients with Early Prostate Cancer

Unique Data Set IDProstat_AstraZe_1995_102
DownloadableYes
SponsorAstraZenecaData ProviderAstraZenecaTotal Study Enrolled Patients3618Comparator (Control) Arm Enrolled Patients1645RandomizationYesClinicalTrial.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

D6876C00023: A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex TM) Versus Placebo in Patients with Early Prostate Cancer

Trial Summary and Conditions

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

Data Summary

All control arm data collected in the study

Study Objectives

2.1 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.

Outcome Measures

Primary Outcome Measures: ?Time to clinical progression [ Time Frame: Throughout study period ] [ Designated as safety issue: No ] ?Overall patient survival [ Time Frame: Throughout study period ] [ Designated as safety issue: No ] Secondary Outcome Measures: ?Time to treatment failure [ Time Frame: Throughout study period ] [ Designated as safety issue: No ] ?Serum prostate-specific antigen [ Time Frame: Initial study period up to 2006 amended protocol ] [ Designated as safety issue: No ] ?Tolerability in terms of adverse events and laboratory parameters [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]

Available Downloads:

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

PROTOCOL: Casodex CSP D6876C00023_Redacted.pdf

CRF: Sample Case Report Forms 23.pdf

DATA DICTIONARY: 7054IL_0023 data variables.xlsx

DATA (COMPARATOR ARM): Study 23 Package.zip