Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
A Randomized Double-Blind Parallel Group Study Comparing Casodex (or Generic Equivalent) 50mg Plus Placebo to Casodex (or Generic Equivalent) 50mg Plus Dutasteride 3.5mg Administered for 18 Months to Men With Prostate Cancer Who Have Failed First-Line Androgen Deprivation Therapy (Assessed by Rising PSA) Followed by a Two-Year Extension Phase
1 other identifier
interventional
127
2 countries
62
Brief Summary
Dutasteride inhibits the conversion of testosterone to dihydrotestosterone (DHT) the male hormone that leads to benign prostate growth. By blocking the conversion of testosterone to DHT, dutasteride could allow bicalutamide to be a more effective anti-androgen thus prolonging bicalutamide's efficacy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started May 2007
Longer than P75 for phase_4
62 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 7, 2007
CompletedFirst Posted
Study publicly available on registry
May 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
November 1, 2013
CompletedFebruary 27, 2017
November 1, 2016
5.8 years
May 7, 2007
August 29, 2013
January 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Disease Progression
Time to disease progression (PD) is defined as the interval of time between the date of the start of treatment and the date of PD. PD is defined as prostate specific antigen (PSA) progression from Baseline (PSA value is 25% and at least 2 nanograms per milliliter \[ng/mL\] above Baseline, confirmed by a second PSA value); PSA progression from nadir, without a 50% decrease from Baseline (PSA value is 25% and at least 2 ng/mL above nadir, confirmed by a second PSA value); PSA progression from nadir, with a 50% or more decrease from Baseline (PSA value is 50% and at least 2 ng/mL above nadir, confirmed by a second PSA value); metastatic disease (radiographic evidence of metastatic disease); death due to prostate cancer; or the receipt of post-Baseline rescue medication. PSA confirmation was not required if no subsequent PSA values were available. Participants who did not experience an event were censored at the date of the latest follow-up information.
Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)
Secondary Outcomes (4)
Time to Treatment Failure
Interval of time between the date of the start of treatment and the date of treatment failure (up to Study Month 42)
Number of Participants With PSA Response
Time from Baseline PSA measurement until the first PSA measurement with a 50% or greater reduction in PSA values (up to Study Month 42)
Change From Baseline in Total PSA at Months 6, 12, 18, 21, and 42
Baseline and Months 6, 12, 18, 21, and 42
Number of Participants With Metastatic Disease
Interval of time between the date of the start of treatment and the date of radiographic evidence of metastatic disease (up to Study Month 42)
Study Arms (2)
Arm 1
EXPERIMENTAL50 mg bicalutamide and 3.5 mg Dutasteride (IP)
Arm 2
PLACEBO COMPARATOR50 mg bicalutamide and placebo
Interventions
Eligibility Criteria
You may qualify if:
- Men ≥40 and ≤90 years of age
- 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
You may not qualify if:
- Additional hormonal therapy (excluding the current use of a GnRH analogue) within the past 6 months of:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (62)
GSK Investigational Site
Homewood, Alabama, 35209, United States
GSK Investigational Site
Huntsville, Alabama, 35801, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Anaheim, California, 92801, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
San Bernardino, California, 92404, United States
GSK Investigational Site
San Diego, California, 92101, United States
GSK Investigational Site
Denver, Colorado, 80211, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20307, United States
GSK Investigational Site
Aventura, Florida, 33180, United States
GSK Investigational Site
Daytona Beach, Florida, 32114, United States
GSK Investigational Site
Orlando, Florida, 32803, United States
GSK Investigational Site
Galesburg, Illinois, 61401, United States
GSK Investigational Site
Evansville, Indiana, 47713, United States
GSK Investigational Site
Fort Wayne, Indiana, 46825, United States
GSK Investigational Site
Jeffersonville, Indiana, 47130, United States
GSK Investigational Site
Overland Park, Kansas, 66211, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
Shreveport, Louisiana, 71106, United States
GSK Investigational Site
Annapolis, Maryland, 21401, United States
GSK Investigational Site
Watertown, Massachusetts, 02472, United States
GSK Investigational Site
Chaska, Minnesota, 55318, United States
GSK Investigational Site
Minneapolis, Minnesota, 55455, United States
GSK Investigational Site
St Louis, Missouri, 63136, United States
GSK Investigational Site
Omaha, Nebraska, 68114, United States
GSK Investigational Site
Las Vegas, Nevada, 89148, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
Garden City, New York, 11530, United States
GSK Investigational Site
Manhasset, New York, 11030, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Concord, North Carolina, 28025, United States
GSK Investigational Site
Columbus, Ohio, 43214, United States
GSK Investigational Site
Bala-Cynwyd, Pennsylvania, 19004, United States
GSK Investigational Site
Lancaster, Pennsylvania, 17604, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Myrtle Beach, South Carolina, 29572, United States
GSK Investigational Site
Memphis, Tennessee, 38119, United States
GSK Investigational Site
Houston, Texas, 77074, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Norfork, Virginia, 23502, United States
GSK Investigational Site
Richmond, Virginia, 23235, United States
GSK Investigational Site
Virginia Beach, Virginia, 23454, United States
GSK Investigational Site
Williamsburg, Virginia, 23185, United States
GSK Investigational Site
Seattle, Washington, 98166, United States
GSK Investigational Site
Seattle, Washington, 98195-6015, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, United States
GSK Investigational Site
Calgary, Alberta, T2V 1P9, Canada
GSK Investigational Site
Surrey, British Columbia, V3V 1N1, Canada
GSK Investigational Site
Victoria, British Columbia, V8T 5G1, Canada
GSK Investigational Site
Barrie, Ontario, L4M 7G1, Canada
GSK Investigational Site
Burlington, Ontario, L7S 1V2, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 4T3, Canada
GSK Investigational Site
North Bay, Ontario, P1B 7K8, Canada
GSK Investigational Site
Oakville, Ontario, L6H 3P1, Canada
GSK Investigational Site
Scarborough Village, Ontario, M1S 4V5, Canada
GSK Investigational Site
Toronto, Ontario, M2K 2W1, Canada
GSK Investigational Site
Toronto, Ontario, M4C 5T2, Canada
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H3, Canada
GSK Investigational Site
Laval, Quebec, H7G 2E6, Canada
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3, Canada
GSK Investigational Site
Québec, Quebec, G1R 2J6, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2007
First Posted
May 8, 2007
Study Start
May 1, 2007
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 27, 2017
Results First Posted
November 1, 2013
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.