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

Verified by: AstraZeneca, March 2009
First Received: April 7, 2008 | Last Updated: March 10, 2009 | Phase: Phase 3 | Start Date: August 1995
Overall Status: Completed | Estimated Enrollment: 3618
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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...

Brief Summary

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

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation 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 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

Clinical Trial Investigator Information

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

William See Principal Investigator Medical College of Wisconsin  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00657904