A Randomized, Double-Blind, Parallel-Group Trial Comparing Casodex 150mg Once Daily With Placebo in Patients With Non-Metastatic Prostate Cancer.

AstraZeneca1 site in 1 country1,218 target enrollmentOctober 1995

ConditionsNon-Metastatic Prostate Cancer

InterventionsPlacebo Bicalutamide

DrugsBicalutamide Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Non-Metastatic Prostate Cancer
Sponsor: AstraZeneca
Enrollment: 1218
Locations: 1
Primary Endpoint: Survival
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 1995

End Date

August 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of non-metastatic cancer of the prostate gland
•Patient to be 18 years and above

Exclusion Criteria

•Previous systemic therapy for prostate cancer
•Previous history of another form of cancer (not prostate) within 5 years of study start.

Arms & Interventions

A

Intervention: Placebo

B

Intervention: Bicalutamide

Outcomes

Primary Outcomes

Survival

Time Frame: Throughout study period

Time to clinical progression

Time Frame: Throughout study period

Secondary Outcomes

Tolerability in terms of adverse events and laboratory parameters(Throughout study period)
Time to treatment failure(Throughout study period)
Prostate-specific antigen(Initial study period up to 2005 amended protocol)