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

NCT ID: NCT00657904

Last Updated: 2012-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

3618 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-08-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Non-metastatic Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Bicalutamide

Intervention Type DRUG

150mg daily

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once daily

Interventions

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Bicalutamide

150mg daily

Intervention Type DRUG

Placebo

once daily

Intervention Type DRUG

Other Intervention Names

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Casodex™

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William See

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

David G. McLeod

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Medical Center

Locations

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Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Berkeley, California, United States

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Laguna Woods, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Monica, California, United States

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Thousand Oaks, California, United States

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Torrance, California, United States

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Van Nuys, California, United States

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Denver, Colorado, United States

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Middlebury, Connecticut, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Aventura, Florida, United States

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Bay Pines, Florida, United States

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Boca Raton, Florida, United States

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Daytona Beach, Florida, United States

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Fort Myers, Florida, United States

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Gainesville, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Saint Augustine, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Fort Wayne, Indiana, United States

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Greenwood, Indiana, United States

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Iowa City, Iowa, United States

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Kansas City, Kansas, United States

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Louisville, Kentucky, United States

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Shreveport, Louisiana, United States

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Greenbelt, Maryland, United States

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Rockville, Maryland, United States

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Burlington, Massachusetts, United States

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Newtown, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Rochester, Minnesota, United States

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Hattiesburg, Mississippi, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Lebanon, New Hampshire, United States

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Albany, New York, United States

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Manhasset, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Asheville, North Carolina, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Cincinnati, Ohio, United States

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Portland, Oregon, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Cordova, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Danville, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Cheyenne, Wyoming, United States

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Calgary, Alberta, Canada

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Edmonton, Alberta, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Hamilton, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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North York, Ontario, Canada

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Oakville, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, , Canada

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Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 22129214 (View on PubMed)

Other Identifiers

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7054IL/0023

Identifier Type: -

Identifier Source: secondary_id

D6876C00023

Identifier Type: -

Identifier Source: org_study_id

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