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

Condition(s) targeted: Prostate Cancer

Intervention: dutasteride (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

Time to treatment failure with up to 18 months of treatment by PSA progression form baseline or evidence of metastatic disease

Percentage of subjects having metastatic disease after up to 18 months of treatment

Time to Treatment Failure for subjects with up to 18 months of treatment - summarized in the table below.

Change in PSA value from baseline during up to 18 months of treatment

Time to disease progression, time to treatment failure, percentage of subjects having PSA response, change in PSA values from baseline,

and percentage of subjects having metastatic disease for subjects with up to 42 months of treatment (including the two-year extension phase).

Minimum age: 40 Years. Maximum age: 90 Years. Gender(s): Male.

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.

US GSK Clinical Trials Call Center, Phone: 877-379-3718

GSK Investigational Site, Quebec G1R 2J6, Canada; Active, not recruiting

GSK Investigational Site, Homewood, Alabama 35209, United States; Recruiting

GSK Investigational Site, Huntsville, Alabama 35801, United States; Completed

GSK Investigational Site, Calgary, Alberta T2V 4R6, Canada; Active, not recruiting

GSK Investigational Site, Little Rock, Arkansas 72205, United States; Completed

GSK Investigational Site, Victoria, British Columbia V8T 5G1, Canada; Active, not recruiting

GSK Investigational Site, Surrey, British Columbia V3V 1N1, Canada; Active, not recruiting

GSK Investigational Site, Fresno, California 93720, United States; Recruiting

GSK Investigational Site, Laguna Hills, California 92653, United States; Withdrawn

GSK Investigational Site, San Bernardino, California 92404, United States; Recruiting

GSK Investigational Site, Los Angeles, California 90073, United States; Withdrawn

GSK Investigational Site, Atherton, California 94027, United States; Withdrawn

GSK Investigational Site, Anaheim, California 92801, United States; Active, not recruiting

GSK Investigational Site, Culver City, California 90232, United States; Withdrawn

GSK Investigational Site, San Francisco, California 94108, United States; Withdrawn

GSK Investigational Site, Escondido, California 92025, United States; Withdrawn

GSK Investigational Site, Walnut Creek, California 94598, United States; Withdrawn

GSK Investigational Site, La Mesa, California 91942, United States; Withdrawn

GSK Investigational Site, San Luis Obispo, California 93405, United States; Withdrawn

GSK Investigational Site, San Diego, California 92101, United States; Active, not recruiting

GSK Investigational Site, Tarzana, California 91356, United States; Withdrawn

GSK Investigational Site, Denver, Colorado 80211, United States; Recruiting

GSK Investigational Site, Longmont, Colorado 80501, United States; Withdrawn

GSK Investigational Site, Middlebury, Connecticut 06762, United States; Withdrawn

GSK Investigational Site, Washington, District of Columbia 20307, United States; Recruiting

GSK Investigational Site, Orlando, Florida 32803, United States; Recruiting

GSK Investigational Site, St. Petersburg, Florida 33710, United States; Withdrawn

GSK Investigational Site, Tallahassee, Florida 32308, United States; Withdrawn

GSK Investigational Site, Sarasota, Florida 34237, United States; Withdrawn

GSK Investigational Site, Boca Raton, Florida 33487, United States; Withdrawn

GSK Investigational Site, Coral Gables, Florida 33134, United States; Withdrawn

GSK Investigational Site, Pinecrest, Florida 33156, United States; Withdrawn

GSK Investigational Site, Pembroke Pines, Florida 33024, United States; Withdrawn

GSK Investigational Site, Jacksonville, Florida 32224, United States; Withdrawn

GSK Investigational Site, Ocala, Florida 34474, United States; Withdrawn

GSK Investigational Site, Daytona Beach, Florida 32114, United States; Recruiting

GSK Investigational Site, Aventura, Florida 33180, United States; Completed

GSK Investigational Site, Dawsonville, Georgia 30534, United States; Withdrawn

GSK Investigational Site, Coeur D'Alene, Idaho 83814, United States; Withdrawn

GSK Investigational Site, Galesburg, Illinois 61401, United States; Recruiting

GSK Investigational Site, Winfield, Illinois 60190, United States; Withdrawn

GSK Investigational Site, Belleville, Illinois 62220, United States; Withdrawn

GSK Investigational Site, Melrose Park, Illinois 60160, United States; Withdrawn

GSK Investigational Site, Evansville, Indiana 47713, United States; Recruiting

GSK Investigational Site, Fort Wayne, Indiana 46825, United States; Recruiting

GSK Investigational Site, Avon, Indiana 46123, United States; Withdrawn

GSK Investigational Site, Jeffersonville, Indiana 47714, United States; Recruiting

GSK Investigational Site, Kansas City, Kansas 66160, United States; Withdrawn

GSK Investigational Site, Overland Park, Kansas 66211, United States; Recruiting

GSK Investigational Site, Madisonville, Kentucky 42431, United States; Withdrawn

GSK Investigational Site, Shreveport, Louisiana 71106, United States; Recruiting

GSK Investigational Site, New Orleans, Louisiana 70112, United States; Active, not recruiting

GSK Investigational Site, Annapolis, Maryland 21401, United States; Recruiting

GSK Investigational Site, Greenbelt, Maryland 20770, United States; Withdrawn

GSK Investigational Site, Watertown, Massachusetts 02472, United States; Completed

GSK Investigational Site, West Yarmouth, Massachusetts 02673, United States; Withdrawn

GSK Investigational Site, Worcester, Massachusetts 01605, United States; Withdrawn

GSK Investigational Site, Boston, Massachusetts 02215, United States; Withdrawn

GSK Investigational Site, Boston, Massachusetts 02115, United States; Withdrawn

GSK Investigational Site, Boston, Massachusetts 02135, United States; Withdrawn

GSK Investigational Site, Ann Arbor, Michigan 48109-0330, United States; Withdrawn

GSK Investigational Site, Chaska, Minnesota 55318, United States; Recruiting

GSK Investigational Site, St. Cloud, Minnesota 56303, United States; Withdrawn

GSK Investigational Site, Minneapolis, Minnesota 55455, United States; Not yet recruiting

GSK Investigational Site, St Louis, Missouri 63136, United States; Withdrawn

GSK Investigational Site, St. Louis, Missouri 63124, United States; Withdrawn

GSK Investigational Site, St. Louis, Missouri 63136, United States; Completed

GSK Investigational Site, Missoula, Montana 59802, United States; Withdrawn

GSK Investigational Site, Las Vegas, Nevada 89148, United States; Recruiting

GSK Investigational Site, West Orange, New Jersey 07052, United States; Withdrawn

GSK Investigational Site, Hackensack, New Jersey 07601, United States; Withdrawn

GSK Investigational Site, New York, New York 10016, United States; Completed

GSK Investigational Site, Albany, New York 12208, United States; Recruiting

GSK Investigational Site, Garden City, New York 11530, United States; Active, not recruiting

GSK Investigational Site, Poughkeepsie, New York 12601, United States; Withdrawn

GSK Investigational Site, Manhasset, New York 11030, United States; Active, not recruiting

GSK Investigational Site, Mineola, New York 11501, United States; Withdrawn

GSK Investigational Site, New York, New York 10017, United States; Withdrawn

GSK Investigational Site, New York, New York 10011, United States; Withdrawn

GSK Investigational Site, New York, New York 10032, United States; Withdrawn

GSK Investigational Site, Syracuse, New York 13210, United States; Recruiting

GSK Investigational Site, Durham, North Carolina 27710, United States; Withdrawn

GSK Investigational Site, Gastonia, North Carolina 28054, United States; Not yet recruiting

GSK Investigational Site, Durham, North Carolina 27704, United States; Withdrawn

GSK Investigational Site, Raleigh, North Carolina 27607, United States; Withdrawn

GSK Investigational Site, Winston-Salem, North Carolina 27103, United States; Withdrawn

GSK Investigational Site, Concord, North Carolina 28025, United States; Recruiting

GSK Investigational Site, Gahanna, Ohio 43230, United States; Withdrawn

GSK Investigational Site, Holland, Ohio 43528-8039, United States; Withdrawn

GSK Investigational Site, Cincinnati, Ohio 45267, United States; Withdrawn

GSK Investigational Site, Cincinnati, Ohio 45212, United States; Withdrawn

GSK Investigational Site, Columbus, Ohio 43214, United States; Completed

GSK Investigational Site, Scarborough, Ontario M1S 4V5, Canada; Active, not recruiting

GSK Investigational Site, Sudbury, Ontario P3E 4T3, Canada; Active, not recruiting

GSK Investigational Site, Burlington, Ontario L7S 1V2, Canada; Recruiting

GSK Investigational Site, Toronto, Ontario M2K 2W1, Canada; Recruiting

GSK Investigational Site, Toronto, Ontario M4C 5T2, Canada; Active, not recruiting

GSK Investigational Site, Barrie, Ontario L4M 7G1, Canada; Not yet recruiting

GSK Investigational Site, North Bay, Ontario P1B 7K8, Canada; Active, not recruiting

GSK Investigational Site, Oakville, Ontario L6H 3P1, Canada; Recruiting

GSK Investigational Site, Lancaster, Pennsylvania 17604, United States; Recruiting

GSK Investigational Site, Philadelphia, Pennsylvania 19152, United States; Withdrawn

GSK Investigational Site, Sellersville, Pennsylvania 18960, United States; Withdrawn

GSK Investigational Site, Pittsburgh, Pennsylvania 15532, United States; Withdrawn

GSK Investigational Site, Bala Cynwyd, Pennsylvania 19004, United States; Recruiting

GSK Investigational Site, Philadelphia, Pennsylvania 19107, United States; Recruiting

GSK Investigational Site, Pointe-Claire, Quebec H9R 4S3, Canada; Recruiting

GSK Investigational Site, Greenfield Park, Quebec J4V 2H3, Canada; Active, not recruiting

GSK Investigational Site, Laval, Quebec H7G 2E6, Canada; Active, not recruiting

GSK Investigational Site, Myrtle Beach, South Carolina 29572, United States; Completed

GSK Investigational Site, Memphis, Tennessee 38119, United States; Active, not recruiting

GSK Investigational Site, Dallas, Texas 75231, United States; Withdrawn

GSK Investigational Site, Houston, Texas 77024, United States; Withdrawn

GSK Investigational Site, San Antonio, Texas 78229, United States; Withdrawn

GSK Investigational Site, San Antonio, Texas 78229, United States; Completed

GSK Investigational Site, Amarillo, Texas 79106, United States; Withdrawn

GSK Investigational Site, Houston, Texas 77074, United States; Recruiting

GSK Investigational Site, Norfolk, Virginia 23502, United States; Recruiting

GSK Investigational Site, Williamsburg, Virginia 23185, United States; Recruiting

GSK Investigational Site, Richmond, Virginia 23235, United States; Withdrawn

GSK Investigational Site, Richmond, Virginia 23249, United States; Withdrawn

GSK Investigational Site, Charlottesville, Virginia 22908, United States; Withdrawn

GSK Investigational Site, Richmond, Virginia 23235, United States; Recruiting

GSK Investigational Site, Virginia Beach, Virginia 23454, United States; Completed

GSK Investigational Site, Spokane, Washington 99202, United States; Withdrawn

GSK Investigational Site, Tacoma, Washington 98431, United States; Withdrawn

GSK Investigational Site, Seattle, Washington 98101, United States; Withdrawn

GSK Investigational Site, Spokane Valley, Washington 99216, United States; Withdrawn

GSK Investigational Site, Seattle, Washington 98195-6015, United States; Recruiting

GSK Investigational Site, Burien, Washington 98166, United States; Recruiting

GSK Investigational Site, Milwaukee, Wisconsin 53226, United States; Active, not recruiting

Starting date: May 2007
Ending date: May 2009
Last updated: February 12, 2009