Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer

Phase 3

Completed

• Conditions: Non-metastatic Prostate Cancer
• Interventions: Drug: Placebo; Drug: Bicalutamide

• Registration Number: NCT00657904
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1995-08
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-14
• Primary Completion: 2008-07
• Study Completion: 2008-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 3618

Inclusion Criteria

• Prostate cancer in the early stage of disease
• Prostate removed and/or radiation therapy to the prostate area

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Bicalutamide	-

Primary Outcome Measures

Name	Time	Method
Time to clinical progression	Throughout study period
Overall patient survival	Throughout study period

Secondary Outcome Measures

Name	Time	Method
Time to treatment failure	Throughout study period
Serum prostate-specific antigen	Initial study period up to 2006 amended protocol
Tolerability in terms of adverse events and laboratory parameters	Throughout study period

Trial Locations

Locations (1)

Research Site; 🇨🇦 Quebec, Canada