Casodex vs Placebo in Non-Metastatic Early Prostate Cancer

Phase 3

Completed

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

• Registration Number: NCT00672282
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1995-10
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-06
• Study Completion: 2008-08
• Status Verified: 2009-03
• Last Update Submitted: 2009-05-26
• Last Update Posted: 2009-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1218

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Placebo	-
B	Bicalutamide	-

Primary Outcome Measures

Name	Time	Method
Survival	Throughout study period
Time to clinical progression	Throughout study period

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇪 Vostervik, Sweden