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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00657904
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):

April 7, 2008
April 14, 2008
June 6, 2012
August 1995
July 2008   (Final data collection date for primary outcome measure)
  • Time to clinical progression [ Time Frame: Throughout study period ]
  • Overall patient survival [ Time Frame: Throughout study period ]
Same as current
Complete list of historical versions of study NCT00657904 on Archive Site
  • 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 ]
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
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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. doi: 10.1111/j.1464-410X.2010.09319.x.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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.
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
Not Provided
Not Provided
Not Provided
Principal Investigator: William See Medical College of Wisconsin
Principal Investigator: David G. McLeod Walter Reed Army Medical Center
June 2012

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