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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

April 7, 2008
June 5, 2012
August 1995
July 2008   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00657904 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Non-metastatic Prostate Cancer
  • Drug: Bicalutamide
    150mg daily
    Other Name: Casodex™
  • Drug: Placebo
    once daily
  • Experimental: 1
    Intervention: Drug: Bicalutamide
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Iversen P, McLeod DG, See WA, Morris T, Armstrong J, Wirth MP; Casodex Early Prostate Cancer Trialists' Group. Antiandrogen monotherapy in patients with localized or locally advanced prostate cancer: final results from the bicalutamide Early Prostate Cancer programme at a median follow-up of 9.7 years. BJU Int. 2010 Apr;105(8):1074-81.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3618
August 2008
July 2008   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00657904
D6876C00023, 7054IL/0023
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: William See Medical College of Wisconsin
Principal Investigator: David G. McLeod Walter Reed Army Medical Center
AstraZeneca
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP