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Prostate

D6876C00025: A Randomised, Double-blind, Parallel-group Trial Comparing Casodex TM 150 mg Once Daily With Placebo In Subjects With Non-metastatic Prostate Cancer (SPCG-6)

Unique Data Set IDProstat_AstraZe_1995_106
DownloadableYes
SponsorAstraZenecaData ProviderAstraZenecaTotal Study Enrolled Patients1218Comparator (Control) Arm Enrolled Patients611RandomizationYesClinicalTrial.gov IDNCT00672282ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00672282?term=D6876C00025&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeOther

Clinical Trial Title

D6876C00025: A Randomised, Double-blind, Parallel-group Trial Comparing Casodex TM 150 mg Once Daily With Placebo In Subjects With Non-metastatic Prostate Cancer (SPCG-6)

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. 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 data collected fro 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 overall survival. 2. To compare Casodex 150 mg once daily with placebo in terms of time to clinical progression in patients with non-metastatic prostate cancer. 3. 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 time to treatment failure. 2. To assess the time taken for prostate specific antigen (PSA) to double. 3. To assess sexual function using the GRISS questionnaire.

Outcome Measures

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

Available Downloads:

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

PROTOCOL: Casodex CSP D6876C00025_Redacted.pdf

CRF: Sample_Case_Report_Forms 25.pdf

DATA DICTIONARY: 7054IL_0025 data variables.xlsx

DATA (COMPARATOR ARM): Study 25 package.zip