Last updated: 11/07/2018 15:49:38

Prostate Cancer Study In Men Who Have Failed First-Line Androgen Deprivation Therapy

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GSK study ID
AVO108943
See study documents
Clinicaltrials.gov ID
NCT00470834
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Drug: dutasteride
  • Drug: placebo
  • Drug: bicalutamide
    • 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
    • Inclusion criteria:
    • Men ≥40 and ≤90 years of age
    Inclusion and exclusion criteria
    Inclusion 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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Fresno, California, United States, 93720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98195-6015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Syracuse, New York, United States, 13210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72205
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68114
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Huntsville, Alabama, United States, 35801
    Status
    Terminated/Withdrawn
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    Showing 1 - 6 of 62 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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.

    Additional information about the trial

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