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.
2 other identifiers
interventional
3,618
2 countries
85
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 1995
Longer than P75 for phase_3
85 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 1995
CompletedFirst Submitted
Initial submission to the registry
April 7, 2008
CompletedFirst Posted
Study publicly available on registry
April 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedJune 6, 2012
June 1, 2012
12.9 years
April 7, 2008
June 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to clinical progression
Throughout study period
Overall patient survival
Throughout study period
Secondary Outcomes (3)
Time to treatment failure
Throughout study period
Serum prostate-specific antigen
Initial study period up to 2006 amended protocol
Tolerability in terms of adverse events and laboratory parameters
Throughout study period
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Prostate cancer in the early stage of disease
- Prostate removed and/or radiation therapy to the prostate area
You may not qualify if:
- Previous systemic therapy for prostate cancer
- Previous history of another form of cancer (not prostate) within 5 years of study start.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (85)
Research Site
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
Research Site
Québec, Canada
Related Publications (1)
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.
PMID: 22129214DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
William See
Medical College of Wisconsin
- PRINCIPAL INVESTIGATOR
David G. McLeod
Walter Reed Army Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2008
First Posted
April 14, 2008
Study Start
August 1, 1995
Primary Completion
July 1, 2008
Study Completion
August 1, 2008
Last Updated
June 6, 2012
Record last verified: 2012-06