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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2008

Interventions

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

Arms, Groups and Cohorts

  • Experimental: 1
  • Placebo Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • Time to clinical progression
    • Time Frame: Throughout study period
  • Overall patient survival
    • Time Frame: Throughout study period

Secondary Measures

  • Time to treatment failure
    • Time Frame: Throughout study period
  • Serum prostate-specific antigen
    • Time Frame: Initial study period up to 2006 amended protocol
  • Tolerability in terms of adverse events and laboratory parameters
    • Time Frame: Throughout study period

Participating in This Clinical Trial

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: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • William See, Principal Investigator, Medical College of Wisconsin
    • David G. McLeod, Principal Investigator, Walter Reed Army Medical Center

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