Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
NCT ID: NCT00470834
Last Updated: 2017-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
127 participants
INTERVENTIONAL
2007-05-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1
50 mg bicalutamide and 3.5 mg Dutasteride (IP)
dutasteride
0.5mg dutasteride (Investigation Product)
bicalutamide
50 mg Casodex or generic equivalent
Arm 2
50 mg bicalutamide and placebo
placebo
making placebo
bicalutamide
50 mg Casodex or generic equivalent
Interventions
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dutasteride
0.5mg dutasteride (Investigation Product)
placebo
making placebo
bicalutamide
50 mg Casodex or generic equivalent
Eligibility Criteria
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Inclusion Criteria
* Must have asymptomatic prostate cancer that has progressed during androgen deprivation therapy (rising PSA). PSA progression must have occurred after first-line treatment with GnRH analogues ( e.g. leuprolide, goserelin) or orchiectomy. PSA progression is defined by three rises in PSA each measured at least 4 weeks apart within the previous year.
* Serum PSA ≥2 and ≤20ng/ml from central laboratory. One PSA retest from central laboratory is allowed if the value is \<2 or \>20ng/ml; or if the PSA value is not consistent with the previous rising PSA values that determined progression while on a GnRH analogue.
* Serum Testosterone \<50ng/ml from central laboratory.
* Non-metastatic prostate cancer as confirmed on prior bone scan performed within 8 weeks of screening.
* Expected survival ≥ 2 years
* ECOG Performance status 0, 1, or 2
Exclusion Criteria
* Estrogens (e.g. megestrol, medroxyprogesterone, cyproterone, DES)
* Drugs with antiandrogenic properties (e.g., spironolactone if \>50mg/day, flutamide, bicalutamide\*, ketoconazole\*\*, progestational agents)
\*The use of an antiandrogen during GnRH analogue induction for \<6 weeks is acceptable, but none within the 3 months prior to study entry.
\*\*The use of topical ketoconazole is permitted prior to and during the study. NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto), excluding daily vitamins, during the study is discouraged, but not prohibited. All dietary and herbal supplement usage will be recorded in the eCRF.
* Treatment with oral glucocorticoids during the 3 months prior to randomization or expectation of their use during the study.
* Prior chemotherapy for prostate cancer. (prior prostatectomy or radiotherapy to the prostate are allowed)
* Prostate surgery including TUNA, TURP, TUIP, laser treatment, thermotherapy, balloon dilatation, prosthesis, and cryosurgical ablation within 2 months prior to enrollment.
* Current and/or previous use of the following medications:
* Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 6 months prior to study entry
* Anabolic steroids (within 6 months prior to study entry)
* Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.
* Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes; or peptic ulcer disease which is uncontrolled by medical management.
* Abnormal liver function test greater than 1.5 times the upper limit of normal for alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], alkaline phosphatase \[ALP\] or bilirubin.
* Serum creatinine \>2.0 times the upper limit of normal.
* History of another malignancy within five years that could affect the treatment of prostate cancer or survival of the subject.
* History or current evidence of drug or alcohol abuse within the last 12 months.
* History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject.
* Known hypersensitivity to any 5 alpha-reductase inhibitor or to any drug chemically related to dutasteride.
40 Years
90 Years
MALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Homewood, Alabama, United States
GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Little Rock, Arkansas, United States
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Anaheim, California, United States
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Fresno, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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Denver, Colorado, 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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Daytona Beach, Florida, United States
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Orlando, Florida, United States
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Galesburg, Illinois, United States
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Evansville, Indiana, United States
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Fort Wayne, Indiana, United States
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Jeffersonville, Indiana, United States
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Overland Park, Kansas, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Annapolis, Maryland, United States
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Watertown, Massachusetts, United States
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Chaska, Minnesota, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Albany, New York, United States
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Garden City, 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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Syracuse, New York, United States
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Concord, North Carolina, United States
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Columbus, Ohio, United States
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Bala-Cynwyd, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Myrtle Beach, South Carolina, United States
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Memphis, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Norfork, Virginia, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
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Williamsburg, Virginia, United States
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Seattle, Washington, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Calgary, Alberta, Canada
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Surrey, British Columbia, Canada
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Victoria, British Columbia, Canada
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Barrie, Ontario, Canada
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Burlington, Ontario, Canada
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Greater Sudbury, Ontario, Canada
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North Bay, Ontario, Canada
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Oakville, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Laval, Quebec, Canada
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Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
Countries
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Study Documents
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Document Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Annotated Case Report Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Statistical Analysis Plan
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentRelated Links
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Other Identifiers
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AVO108943
Identifier Type: -
Identifier Source: org_study_id
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