Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00657904

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 III

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.

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:	September 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Bicalutamide 150mg daily
2: Placebo Comparator	Drug: Placebo

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

Responsible Party:	AstraZeneca ( Tom Morris - Medical Science Director )
Study ID Numbers:	D6876C00023, 7054IL/0023
Study First Received:	April 7, 2008
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00657904
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

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Bicalutamide

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Androgen Antagonists
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses

Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009