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

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: Bicalutamide
  • 150mg daily
• Drug: Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Time to clinical progression
  • Time Frame: Throughout study period
    Safety Issue?: No
• Overall patient survival
  • Time Frame: Throughout study period
    Safety Issue?: No

Secondary Measures

• Time to treatment failure
  • Time Frame: Throughout study period
    Safety Issue?: No
• Serum prostate-specific antigen
  • Time Frame: Initial study period up to 2006 amended protocol
    Safety Issue?: No
• Tolerability in terms of adverse events and laboratory parameters
  • Time Frame: Throughout study period
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

William See Principal Investigator Medical College of Wisconsin  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00657904

Study ID Number: D6876C00023

ClinicalTrials.gov Identifier: NCT00657904

Health Authority: United States: Food and Drug Administration