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A Randomized Double-Blind Parallel Group Study Comparing Casodex 50mg Plus Placebo to Casodex 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


Phase 4
40 Years
90 Years
Open (Enrolling)
Male
Neoplasms, Prostate, Prostate Cancer

Thank you

Trial Information

A Randomized Double-Blind Parallel Group Study Comparing Casodex 50mg Plus Placebo to Casodex 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

Inclusion Criteria


Inclusion criteria:

- Men ≥40 and ≤85 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to disease progression with up to 18 months of treatment PSA progression monitored by monthly PSAs

Outcome Time Frame:

18 months, with 2 year safety extension phase

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

AVO108943

NCT ID:

NCT00470834

Start Date:

May 2007

Completion Date:

March 2013

Related Keywords:

  • Neoplasms, Prostate
  • Prostate Cancer
  • prostate cancer
  • androgen deprivation therapy
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteNew Orleans, Louisiana  70112
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteSt. Louis, Missouri  63141
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteGreen Bay, Wisconsin  54301
GSK Investigational SitePark Ridge, Illinois  60068
GSK Investigational SiteBaltimore, Maryland  21201
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteBirmingham, Alabama  35209
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteWashington, District of Columbia  20307-5001
GSK Investigational SiteKansas City, Kansas  66160
GSK Investigational SiteHenderson, Nevada  89014
GSK Investigational SiteSeattle, Washington  98133