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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00657904
Other study ID # D6876C00023
Secondary ID 7054IL/0023
Status Completed
Phase Phase 3
First received April 7, 2008
Last updated June 5, 2012
Start date August 1995
Est. completion date August 2008

Study information

Verified date June 2012
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationCanada: Canadian Institutes of Health ResearchCanada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 3618
Est. completion date August 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Bicalutamide
150mg daily
Placebo
once daily

Locations

Country Name City State
Canada Research Site Calgary Alberta
Canada Research Site Edmonton Alberta
Canada Research Site Halifax Nova Scotia
Canada Research Site Hamilton Ontario
Canada Research Site Kingston Ontario
Canada Research Site London Ontario
Canada Research Site Montreal Quebec
Canada Research Site North York Ontario
Canada Research Site Oakville Ontario
Canada Research Site Quebec
Canada Research Site Toronto Ontario
Canada Research Site Victoria British Columbia
Canada Research Site Winnipeg Manitoba
United States Research Site Albany New York
United States Research Site Ann Arbor Michigan
United States Research Site Asheville North Carolina
United States Research Site Atlanta Georgia
United States Research Site Aventura Florida
United States Research Site Bay Pines Florida
United States Research Site Berkeley California
United States Research Site Birmingham Alabama
United States Research Site Boca Raton Florida
United States Research Site Bronx New York
United States Research Site Burlington Massachusetts
United States Research Site Cheyenne Wyoming
United States Research Site Chicago Illinois
United States Research Site Cincinnati Ohio
United States Research Site Cordova Tennessee
United States Research Site Dallas Texas
United States Research Site Danville Virginia
United States Research Site Daytona Beach Florida
United States Research Site Denver Colorado
United States Research Site Detroit Michigan
United States Research Site Durham North Carolina
United States Research Site Fort Myers Florida
United States Research Site Fort Wayne Indiana
United States Research Site Gainesville Florida
United States Research Site Greenbelt Maryland
United States Research Site Greenwood Indiana
United States Research Site Hattiesburg Mississippi
United States Research Site Houston Texas
United States Research Site Iowa City Iowa
United States Research Site Jackson Mississippi
United States Research Site Kansas City Kansas
United States Research Site Laguna Woods California
United States Research Site Lancaster Pennsylvania
United States Research Site Lebanon New Hampshire
United States Research Site Louisville Kentucky
United States Research Site Madison Wisconsin
United States Research Site Manhasset New York
United States Research Site Miami Florida
United States Research Site Middlebury Connecticut
United States Research Site Milwaukee Wisconsin
United States Research Site Mobile Alabama
United States Research Site Nashville Tennessee
United States Research Site New Haven Connecticut
United States Research Site New York New York
United States Research Site Newport Beach California
United States Research Site Newtown Massachusetts
United States Research Site Ocala Florida
United States Research Site Omaha Nebraska
United States Research Site Philadelphia Pennsylvania
United States Research Site Portland Oregon
United States Research Site Raleigh North Carolina
United States Research Site Richmond Virginia
United States Research Site Rochester New York
United States Research Site Rochester Minnesota
United States Research Site Rockville Maryland
United States Research Site Salt Lake City Utah
United States Research Site San Antonio Texas
United States Research Site San Diego California
United States Research Site San Francisco California
United States Research Site Santa Monica California
United States Research Site Scottsdale Arizona
United States Research Site Seattle Washington
United States Research Site Shreveport Louisiana
United States Research Site St. Augustine Florida
United States Research Site St. Louis Missouri
United States Research Site Syracuse New York
United States Research Site Thousand Oaks California
United States Research Site Torrance California
United States Research Site Tucson Arizona
United States Research Site Van Nuys California
United States Research Site Virginia Beach Virginia
United States Research Site Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to clinical progression Throughout study period No
Primary Overall patient survival Throughout study period No
Secondary Time to treatment failure Throughout study period No
Secondary Serum prostate-specific antigen Initial study period up to 2006 amended protocol No
Secondary Tolerability in terms of adverse events and laboratory parameters Throughout study period Yes
See also
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Completed NCT00673205 - (Bicalutamide) Casodex vs Placebo in Non-metastatic Early Prostate Cancer Phase 3
Completed NCT00672282 - Casodex vs Placebo in Non-Metastatic Early Prostate Cancer Phase 3
Recruiting NCT06202248 - A Study to Assess Alpha DaRT224 for the Treatment of Men With Non-metastatic Locally Recurrent Prostate Cancer N/A
Recruiting NCT01317043 - A Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy Phase 2
Completed NCT06204302 - An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States
Completed NCT00239291 - Safety Study to Explore Combination of Gefitinib (ZD1839, Iressa) and Radiotherapy in Non-Metastatic Prostate Cancer Phase 1/Phase 2
Recruiting NCT04049747 - Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer N/A
Active, not recruiting NCT05617885 - Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer Phase 1/Phase 2