Last updated: 11/07/2018 15:49:38
Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Time to disease progression
Timeframe: Interval of time between the date of the start of treatment and the date of disease progression (up to Study Month 42)
Secondary outcomes:
Time to treatment failure
Timeframe: 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
Timeframe: 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
Timeframe: Baseline and Months 6, 12, 18, 21, and 42
Number of participants with metastatic disease
Timeframe: 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)
Interventions:
Enrollment:
127
Primary completion date:
2013-25-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Franklin M. Chu, Oliver Sartor, Leonard Gomella, Todd Rudo, Matthew C. Somerville, Belinda Hereghty, Michael J. Manyak. A randomized, double blind study comparing the addition of bicalutamide with or without dutasteride to GnRH analogue therapy in men with non-metastatic castrate-resistant prostate cancer. Eur J Cancer.2015;51(12):1555-1569.
Medical condition
Neoplasms, Prostate
Product
bicalutamide, dutasteride
Collaborators
GSK
Study date(s)
May 2007 to February 2013
Type
Interventional
Phase
4
Participation criteria
Sex
Male
Age
40 - 90 years
Accepts healthy volunteers
No
- 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.
- Additional hormonal therapy (excluding the current use of a GnRH analogue) within the past 6 months of:
- Estrogens (e.g. megestrol, medroxyprogesterone, cyproterone, DES)
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
- 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.
Trial location(s)
Location
GSK Investigational Site
Fresno, California, United States, 93720
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98195-6015
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Omaha, Nebraska, United States, 68114
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Huntsville, Alabama, United States, 35801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Albany, New York, United States, 12208
Status
Study Complete
Location
GSK Investigational Site
San Bernardino, California, United States, 92404
Status
Study Complete
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V3V 1N1
Status
Study Complete
Location
GSK Investigational Site
Homewood, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Chaska, Minnesota, United States, 55318
Status
Study Complete
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825
Status
Study Complete
Location
GSK Investigational Site
Aventura, Florida, United States, 33180
Status
Study Complete
Location
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Seattle, Washington, United States, 98166
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63136
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71106
Status
Study Complete
Location
GSK Investigational Site
Watertown, Massachusetts, United States, 02472
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Richmond, Virginia, United States, 23235
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89148
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8T 5G1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Bay, Ontario, Canada, P1B 7K8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Annapolis, Maryland, United States, 21401
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20307
Status
Study Complete
Location
GSK Investigational Site
Galesburg, Illinois, United States, 61401
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Study Complete
Location
GSK Investigational Site
Williamsburg, Virginia, United States, 23185
Status
Study Complete
Location
GSK Investigational Site
Daytona Beach, Florida, United States, 32114
Status
Study Complete
Location
GSK Investigational Site
Jeffersonville, Indiana, United States, 47130
Status
Study Complete
Location
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 4T3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Denver, Colorado, United States, 80211
Status
Study Complete
Location
GSK Investigational Site
Toronto, Ontario, Canada, M4C 5T2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Concord, North Carolina, United States, 28025
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32803
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Garden City, New York, United States, 11530
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Norfork, Virginia, United States, 23502
Status
Study Complete
Location
GSK Investigational Site
Virginia Beach, Virginia, United States, 23454
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Diego, California, United States, 92101
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lancaster, Pennsylvania, United States, 17604
Status
Study Complete
Location
GSK Investigational Site
Myrtle Beach, South Carolina, United States, 29572
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Evansville, Indiana, United States, 47713
Status
Study Complete
Location
GSK Investigational Site
Bala Cynwyd, Pennsylvania, United States, 19004
Status
Study Complete
Location
GSK Investigational Site
Columbus, Ohio, United States, 43214
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H3
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Manhasset, New York, United States, 11030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2013-25-02
Actual study completion date
2013-25-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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