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

Non-metastatic Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657904
• Other study ID #: D6876C00023
• Secondary ID: 7054IL/0023
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2008
• Last updated: June 5, 2012
• Start date: August 1995
• Est. completion date: August 2008

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Canadian Institutes of Health ResearchCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3618
• Est. completion date: August 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non-metastatic Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Bicalutamide
150mg daily
• Placebo
once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to clinical progression		Throughout study period	No
Primary	Overall patient survival		Throughout study period	No
Secondary	Time to treatment failure		Throughout study period	No
Secondary	Serum prostate-specific antigen		Initial study period up to 2006 amended protocol	No
Secondary	Tolerability in terms of adverse events and laboratory parameters		Throughout study period	Yes