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

Tracking Information

First Received Date ^ICMJE

April 7, 2008

Last Updated Date

March 10, 2009

Start Date ^ICMJE

August 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00657904 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Non-Metastatic Prostate Cancer

Intervention ^ICMJE

Drug: Bicalutamide
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3618

Completion Date

August 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00657904

Responsible Party

Tom Morris - Medical Science Director, AstraZeneca

Study ID Numbers ^ICMJE

D6876C00023, 7054IL/0023

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	William See	Medical College of Wisconsin
Principal Investigator:	David G. McLeod	Walter Reed Army Medical Center

Information Provided By

AstraZeneca

Verification Date

March 2009

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