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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: April 7, 2008
Last updated: June 5, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Non-metastatic Prostate Cancer
Drug: Bicalutamide
Drug: Placebo
Phase 3

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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Time to clinical progression [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Overall patient survival [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to treatment failure [ Time Frame: Throughout study period ] [ Designated as safety issue: No ]
  • Serum prostate-specific antigen [ Time Frame: Initial study period up to 2006 amended protocol ] [ Designated as safety issue: No ]
  • Tolerability in terms of adverse events and laboratory parameters [ Time Frame: Throughout study period ] [ Designated as safety issue: Yes ]

Enrollment: 3618
Study Start Date: August 1995
Study Completion Date: August 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Bicalutamide
150mg daily
Other Name: Casodex™
Placebo Comparator: 2 Drug: Placebo
once daily


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00657904

  Show 85 Study Locations
Sponsors and Collaborators
Principal Investigator: William See Medical College of Wisconsin
Principal Investigator: David G. McLeod Walter Reed Army Medical Center
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00657904     History of Changes
Other Study ID Numbers: D6876C00023  7054IL/0023 
Study First Received: April 7, 2008
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration
Canada: Canadian Institutes of Health Research
Canada: Health Canada

Keywords provided by AstraZeneca:
androgen antagonists
prostate neoplasms

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Androgen Antagonists
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 24, 2016