Full Text View
Tabular View
No Study Results Posted
Related Studies
Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer
This study has been completed.
First Received: April 7, 2008   Last Updated: March 10, 2009   History of Changes
Sponsor: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00657904
  Purpose

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.


Condition Intervention Phase
Non-Metastatic Prostate Cancer
 Drug: Bicalutamide
Drug: Placebo
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Bicalutamide
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to clinical progression [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Overall patient survival [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Serum prostate-specific antigen [ Time Frame: Initial study period up to 2006 amended protocol ] [ Designated as safety issue: No ]
  • Tolerability in terms of adverse events and laboratory parameters [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]

Enrollment: 3618
Study Start Date: August 1995
Study Completion Date: August 2008
Arms Assigned Interventions
1: Experimental Drug: Bicalutamide
150mg daily
2: Placebo Comparator Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657904

  Hide Study Locations
Locations
United States, Alabama
Research Site
BIRMINGHAM, Alabama, United States
Research Site
MOBILE, Alabama, United States
United States, Arizona
Research Site
SCOTTSDALE, Arizona, United States
Research Site
TUCSON, Arizona, United States
United States, California
Research Site
BERKELEY, California, United States
Research Site
SANTA MONICA, 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
LAGUNA WOODS, California, United States
Research Site
THOUSAND OAKS, California, United States
Research Site
TORRANCE, California, United States
Research Site
VAN NUYS, California, United States
United States, Colorado
Research Site
DENVER, Colorado, United States
United States, Connecticut
Research Site
MIDDLEBURY, Connecticut, United States
Research Site
NEW HAVEN, Connecticut, United States
United States, District of Columbia
Research Site
WASHINGTON, District of Columbia, United States
United States, Florida
Research Site
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
United States, Georgia
Research Site
ATLANTA, Georgia, United States
United States, Illinois
Research Site
CHICAGO, Illinois, United States
United States, Indiana
Research Site
FORT WAYNE, Indiana, United States
Research Site
GREENWOOD, Indiana, United States
United States, Iowa
Research Site
IOWA CITY, Iowa, United States
United States, Kansas
Research Site
KANSAS CITY, Kansas, United States
United States, Kentucky
Research Site
LOUISVILLE, Kentucky, United States
United States, Louisiana
Research Site
SHREVEPORT, Louisiana, United States
United States, Maryland
Research Site
GREENBELT, Maryland, United States
Research Site
ROCKVILLE, Maryland, United States
United States, Massachusetts
Research Site
BURLINGTON, Massachusetts, United States
Research Site
NEWTOWN, Massachusetts, United States
United States, Michigan
Research Site
ANN ARBOR, Michigan, United States
Research Site
DETROIT, Michigan, United States
United States, Minnesota
Research Site
ROCHESTER, Minnesota, United States
United States, Mississippi
Research Site
HATTIESBURG, Mississippi, United States
Research Site
JACKSON, Mississippi, United States
United States, Missouri
Research Site
ST. LOUIS, Missouri, United States
United States, Nebraska
Research Site
OMAHA, Nebraska, United States
United States, New Hampshire
Research Site
LEBANON, New Hampshire, United States
United States, New York
Research Site
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
United States, North Carolina
Research Site
ASHEVILLE, North Carolina, United States
Research Site
DURHAM, North Carolina, United States
Research Site
RALEIGH, North Carolina, United States
United States, Ohio
Research Site
CINCINNATI, Ohio, United States
United States, Oregon
Research Site
PORTLAND, Oregon, United States
United States, Pennsylvania
Research Site
LANCASTER, Pennsylvania, United States
Research Site
PHILADELPHIA, Pennsylvania, United States
United States, Tennessee
Research Site
CORDOVA, Tennessee, United States
Research Site
NASHVILLE, Tennessee, United States
United States, Texas
Research Site
DALLAS, Texas, United States
Research Site
HOUSTON, Texas, United States
Research Site
SAN ANTONIO, Texas, United States
United States, Utah
Research Site
SALT LAKE CITY, Utah, United States
United States, Virginia
Research Site
DANVILLE, Virginia, United States
Research Site
RICHMOND, Virginia, United States
Research Site
VIRGINIA BEACH, Virginia, United States
United States, Washington
Research Site
SEATTLE, Washington, United States
United States, Wisconsin
Research Site
MADISON, Wisconsin, United States
Research Site
MILWAUKEE, Wisconsin, United States
United States, Wyoming
Research Site
CHEYENNE, Wyoming, United States
Canada
Research Site
QUEBEC, Canada
Canada, Alberta
Research Site
CALGARY, Alberta, Canada
Research Site
EDMONTON, Alberta, Canada
Canada, British Columbia
Research Site
VICTORIA, British Columbia, Canada
Canada, Manitoba
Research Site
WINNIPEG, Manitoba, Canada
Canada, Nova Scotia
Research Site
HALIFAX, Nova Scotia, Canada
Canada, Ontario
Research Site
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
Canada, Quebec
Research Site
MONTREAL, Quebec, Canada
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: William See Medical College of Wisconsin
Principal Investigator: David G. McLeod Walter Reed Army Medical Center
  More Information

No publications provided

Responsible Party: AstraZeneca ( Tom Morris - Medical Science Director )
Study ID Numbers: D6876C00023, 7054IL/0023
Study First Received: April 7, 2008
Last Updated: March 10, 2009
ClinicalTrials.gov Identifier: NCT00657904     History of Changes
Health Authority: United States: Food and Drug Administration;   Canada: Canadian Institutes of Health Research;   Canada: Health Canada

Keywords provided by AstraZeneca:
androgen antagonists
prostate neoplasms

Additional relevant MeSH terms:
Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Genital Diseases, Male
 Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services