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

Phase 3
18 Years
Not Enrolling
Non-metastatic Prostate Cancer

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Trial Information

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Time to clinical progression

Outcome Time Frame:

Throughout study period

Safety Issue:


Principal Investigator

William See

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical College of Wisconsin


United States: Food and Drug Administration

Study ID:




Start Date:

August 1995

Completion Date:

August 2008

Related Keywords:

  • Non-Metastatic Prostate Cancer
  • androgen antagonists
  • prostate neoplasms
  • Prostatic Neoplasms



Research Site Alabaster, Alabama  
Research Site Mesa, Arizona  
Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Danbury, Connecticut  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Bloomington, Indiana  
Research Site Ames, Iowa  
Research Site Hays, Kansas  
Research Site Ashland, Kentucky  
Research Site Baton Rouge, Louisiana  
Research Site Baltimore, Maryland  
Research Site Beverly, Massachusetts  
Research Site Battle Kreek, Michigan  
Research Site Alexandria, Minnesota  
Research Site Hattiesburg, Mississippi  
Research Site Branson, Missouri  
Research Site Grand Island, Nebraska  
Research Site Hooksett, New Hampshire  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Akron, Ohio  
Research Site Bend, Oregon  
Research Site Allentown, Pennsylvania  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas  
Research Site Ivins, Utah  
Research Site Abington, Virginia  
Research Site Auburn, Washington  
Research Site Appleton, Wisconsin  
Research Site Cheyenne, Wyoming