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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00657904
First received: April 7, 2008
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657904

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov 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 Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgen Antagonists
 Bicalutamide
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013