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

Condition(s) targeted: Non-Metastatic Prostate Cancer

Intervention: Bicalutamide (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
William See, Principal Investigator, Affiliation: Medical College of Wisconsin
David G. McLeod, Principal Investigator, Affiliation: Walter Reed Army Medical Center

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Time to clinical progression

Overall patient survival

Secondary outcome:

Time to treatment failure

Serum prostate-specific antigen

Tolerability in terms of adverse events and laboratory parameters

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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.

Research Site, QUEBEC, Canada

Research Site, BIRMINGHAM, Alabama, United States

Research Site, MOBILE, Alabama, United States

Research Site, CALGARY, Alberta, Canada

Research Site, EDMONTON, Alberta, Canada

Research Site, SCOTTSDALE, Arizona, United States

Research Site, TUCSON, Arizona, United States

Research Site, VICTORIA, British Columbia, Canada

Research Site, 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, DENVER, Colorado, United States

Research Site, MIDDLEBURY, Connecticut, United States

Research Site, NEW HAVEN, Connecticut, United States

Research Site, WASHINGTON, District of Columbia, United States

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

Research Site, ATLANTA, Georgia, United States

Research Site, CHICAGO, Illinois, United States

Research Site, FORT WAYNE, Indiana, United States

Research Site, GREENWOOD, Indiana, United States

Research Site, IOWA CITY, Iowa, United States

Research Site, KANSAS CITY, Kansas, United States

Research Site, LOUISVILLE, Kentucky, United States

Research Site, SHREVEPORT, Louisiana, United States

Research Site, WINNIPEG, Manitoba, Canada

Research Site, GREENBELT, Maryland, United States

Research Site, ROCKVILLE, Maryland, United States

Research Site, BURLINGTON, Massachusetts, United States

Research Site, NEWTOWN, Massachusetts, United States

Research Site, ANN ARBOR, Michigan, United States

Research Site, DETROIT, Michigan, United States

Research Site, ROCHESTER, Minnesota, United States

Research Site, HATTIESBURG, Mississippi, United States

Research Site, JACKSON, Mississippi, United States

Research Site, ST. LOUIS, Missouri, United States

Research Site, OMAHA, Nebraska, United States

Research Site, LEBANON, New Hampshire, United States

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

Research Site, ASHEVILLE, North Carolina, United States

Research Site, DURHAM, North Carolina, United States

Research Site, RALEIGH, North Carolina, United States

Research Site, HALIFAX, Nova Scotia, Canada

Research Site, CINCINNATI, Ohio, United States

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

Research Site, PORTLAND, Oregon, United States

Research Site, LANCASTER, Pennsylvania, United States

Research Site, PHILADELPHIA, Pennsylvania, United States

Research Site, MONTREAL, Quebec, Canada

Research Site, CORDOVA, Tennessee, United States

Research Site, NASHVILLE, Tennessee, United States

Research Site, DALLAS, Texas, United States

Research Site, HOUSTON, Texas, United States

Research Site, SAN ANTONIO, Texas, United States

Research Site, SALT LAKE CITY, Utah, United States

Research Site, DANVILLE, Virginia, United States

Research Site, RICHMOND, Virginia, United States

Research Site, VIRGINIA BEACH, Virginia, United States

Research Site, SEATTLE, Washington, United States

Research Site, MADISON, Wisconsin, United States

Research Site, MILWAUKEE, Wisconsin, United States

Research Site, CHEYENNE, Wyoming, United States

Starting date: August 1995
Ending date: September 2008
Last updated: June 12, 2008