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

NCT00657904 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3618

Last updated 2012-06-06

No results posted yet for this study

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.

Conditions

  • Non-metastatic Prostate Cancer

Interventions

DRUG

Bicalutamide

150mg daily

DRUG

Placebo

once daily

Sponsors & Collaborators

Principal Investigators

  • William See · Medical College of Wisconsin

  • David G. McLeod · Walter Reed Army Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-08-31
Primary Completion
2008-07-31
Completion
2008-08-31

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00657904 on ClinicalTrials.gov