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

June 5, 2012 updated by: AstraZeneca

A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3618

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Victoria, British Columbia, Canada
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Hamilton, Ontario, Canada
        • Research Site
      • Kingston, Ontario, Canada
        • Research Site
      • London, Ontario, Canada
        • Research Site
      • North York, Ontario, Canada
        • Research Site
      • Oakville, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Research Site
      • Mobile, Alabama, United States
        • Research Site
    • Arizona
      • Scottsdale, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • California
      • Berkeley, California, United States
        • Research Site
      • Laguna Woods, California, United States
        • Research Site
      • Newport Beach, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
      • San Francisco, California, United States
        • Research Site
      • Santa Monica, California, United States
        • Research Site
      • Thousand Oaks, California, United States
        • Research Site
      • Torrance, California, United States
        • Research Site
      • Van Nuys, California, United States
        • Research Site
    • Colorado
      • Denver, Colorado, United States
        • Research Site
    • Connecticut
      • Middlebury, Connecticut, United States
        • Research Site
      • New Haven, Connecticut, United States
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States
        • Research Site
    • Florida
      • Aventura, Florida, United States
        • Research Site
      • Bay Pines, Florida, United States
        • Research Site
      • Boca Raton, Florida, United States
        • Research Site
      • Daytona Beach, Florida, United States
        • Research Site
      • Fort Myers, Florida, United States
        • Research Site
      • Gainesville, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • Ocala, Florida, United States
        • Research Site
      • St. Augustine, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Illinois
      • Chicago, Illinois, United States
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States
        • Research Site
      • Greenwood, Indiana, United States
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States
        • Research Site
    • Maryland
      • Greenbelt, Maryland, United States
        • Research Site
      • Rockville, Maryland, United States
        • Research Site
    • Massachusetts
      • Burlington, Massachusetts, United States
        • Research Site
      • Newtown, Massachusetts, United States
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Research Site
      • Detroit, Michigan, United States
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States
        • Research Site
    • Mississippi
      • Hattiesburg, Mississippi, United States
        • Research Site
      • Jackson, Mississippi, United States
        • Research Site
    • Missouri
      • St. Louis, Missouri, United States
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Research Site
    • New York
      • Albany, New York, United States
        • Research Site
      • Bronx, New York, United States
        • Research Site
      • Manhasset, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
      • Syracuse, New York, United States
        • Research Site
    • North Carolina
      • Asheville, North Carolina, United States
        • Research Site
      • Durham, North Carolina, United States
        • Research Site
      • Raleigh, North Carolina, United States
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Research Site
    • Oregon
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Lancaster, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
    • Tennessee
      • Cordova, Tennessee, United States
        • Research Site
      • Nashville, Tennessee, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
      • Houston, Texas, United States
        • Research Site
      • San Antonio, Texas, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Virginia
      • Danville, Virginia, United States
        • Research Site
      • Richmond, Virginia, United States
        • Research Site
      • Virginia Beach, Virginia, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States
        • Research Site
      • Milwaukee, Wisconsin, United States
        • Research Site
    • Wyoming
      • Cheyenne, Wyoming, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Bicalutamide
150mg daily
Other Names:
  • Casodex™
Placebo Comparator: 2
Drug: Placebo
once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to clinical progression
Time Frame: Throughout study period
Throughout study period
Overall patient survival
Time Frame: Throughout study period
Throughout study period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: William See, Medical College of Wisconsin
  • Principal Investigator: David G. McLeod, Walter Reed Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1995

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

April 7, 2008

First Submitted That Met QC Criteria

April 11, 2008

First Posted (Estimate)

April 14, 2008

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D6876C00023
  • 7054IL/0023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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