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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



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