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

Primary Purpose

Non-metastatic Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bicalutamide
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-metastatic Prostate Cancer focused on measuring androgen antagonists, prostate neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Time to clinical progression
Overall patient survival

Secondary Outcome Measures

Time to treatment failure
Serum prostate-specific antigen
Tolerability in terms of adverse events and laboratory parameters

Full Information

First Posted
April 7, 2008
Last Updated
June 5, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00657904
Brief Title
Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer
Official Title
A Randomized Double-Blind Comparative Trial of Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 1995 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-metastatic Prostate Cancer
Keywords
androgen antagonists, prostate neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3618 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Other Intervention Name(s)
Casodex™
Intervention Description
150mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily
Primary Outcome Measure Information:
Title
Time to clinical progression
Time Frame
Throughout study period
Title
Overall patient survival
Time Frame
Throughout study period
Secondary Outcome Measure Information:
Title
Time to treatment failure
Time Frame
Throughout study period
Title
Serum prostate-specific antigen
Time Frame
Initial study period up to 2006 amended protocol
Title
Tolerability in terms of adverse events and laboratory parameters
Time Frame
Throughout study period

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William See
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David G. McLeod
Organizational Affiliation
Walter Reed Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
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Birmingham
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Alabama
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United States
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Mobile
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Alabama
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United States
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Scottsdale
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Arizona
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United States
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Tucson
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Berkeley
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United States
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Laguna Woods
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United States
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Newport Beach
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United States
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San Diego
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United States
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San Francisco
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California
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United States
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Santa Monica
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United States
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Thousand Oaks
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Torrance
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United States
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Van Nuys
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Denver
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Colorado
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Middlebury
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New Haven
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Washington
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Aventura
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Bay Pines
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Boca Raton
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Daytona Beach
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Fort Myers
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Gainesville
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Miami
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Ocala
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St. Augustine
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Atlanta
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Chicago
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Fort Wayne
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Indiana
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Greenwood
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Iowa City
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Louisville
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Shreveport
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Greenbelt
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Rockville
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Burlington
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Newtown
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Ann Arbor
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Detroit
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Rochester
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Jackson
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Bronx
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Manhasset
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New York
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Rochester
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Syracuse
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Asheville
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Durham
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Raleigh
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Cincinnati
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Portland
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Lancaster
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Philadelphia
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Cordova
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Nashville
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Dallas
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Houston
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San Antonio
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Salt Lake City
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Danville
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Richmond
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Virginia Beach
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Seattle
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Madison
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Milwaukee
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Cheyenne
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Calgary
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Canada
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Edmonton
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Canada
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Victoria
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British Columbia
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Canada
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Winnipeg
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Manitoba
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Canada
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Halifax
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Nova Scotia
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Canada
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Hamilton
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Ontario
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Canada
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Kingston
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Ontario
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Canada
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London
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Canada
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North York
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Canada
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Oakville
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Canada
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Toronto
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Ontario
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Canada
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Montreal
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Quebec
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Canada
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Quebec
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Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22129214
Citation
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.
Results Reference
derived

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

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