The primary purpose of the study is to determine if a new sustained-release (depot) formulation of leuprolide, known as Lupron Depot-6 Month, will lower the amount of testosterone (male hormone) in the blood for a period of six months. The way in which the drug, leuprolide, is released from the depot during this time period will also be studied as well as the effect on a marker of prostate cancer known as PSA. The safety of the new formulation will also be studied.

Condition	Treatment or Intervention
Prostatic Neoplasms	Drug: leuprolide acetate for depot suspension

Further Study Details: 

Primary Outcomes: Suppression and maintenance of serum testosterone once suppression is achieved for individual subjects
Secondary Outcomes: Changes in serum PSA and PAP; Subject assessment of symptom severity; ECOG performance status assessment

Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• Histological diagnosis of prostate cancer
• Need for androgen deprivation treatment for 1 year
• Discontinuation from other prostate cancer treatments

Exclusion Criteria:

• Hypersensitivity to leuprolide or polylactic acid

Alabama
      Urology Centers of Alabama, Homewood,  Alabama,  35209,  United States
      Medical Affiliated Research Center, Huntsville,  Alabama,  35801,  United States
Alaska
      Alaska Clinical Research Center, LLC, Anchorage,  Alaska,  99508,  United States
Arkansas
      Arkansas Urology, Little Rock,  Arkansas,  72211,  United States
California
      Center for Urologic Research, La Mesa,  California,  91942,  United States
      San Diego Uro-Research, San Diego,  California,  92101,  United States
      South Orange County Medical Research Center, Laguna Woods,  California,  92653,  United States
      Los Angeles Clinical Research Center, Encino,  California,  91416,  United States
      Urology Associates of Central California, Fresno,  California,  93720,  United States
      Pacific Clinical Center, Encino,  California,  91316,  United States
      Western Clinical Research, Torrance,  California,  90505,  United States
Colorado
      Urology Research Options, Aurora,  Colorado,  80012,  United States
Connecticut
      Connecticut Clinical Research Center, Waterbury,  Connecticut,  06708,  United States
Florida
      Florida Foundation for Healthcare Research, Ocala,  Florida,  34474,  United States
      Advanced Research Institute, New Port Richey,  Florida,  34652,  United States
      South Florida Medical Research, Aventura,  Florida,  33180,  United States
      UroSearch, Inverness,  Florida,  34452,  United States
      Atlantic Urological Associates, Daytona Beach,  Florida,  32114,  United States
      Atlantic Urological Associates, St. Augustine,  Florida,  32086,  United States
      Atlantic Urological Associates, Orange City,  Florida,  32763,  United States
      UroSearch, Ocala,  Florida,  34470,  United States
      Atlantic Urological Associates, New Smyrna Beach,  Florida,  32168,  United States
Georgia
      Georgia Urology, PA, Atlanta,  Georgia,  30342,  United States
      Emory University, Atlanta,  Georgia,  30322,  United States
Illinois
      Specialty Care Research, Peoria,  Illinois,  61614,  United States
      West Side Veteran Administration Medical Center, Chicago,  Illinois,  60602,  United States
      Kankakee Urological Associates, Kankakee,  Illinois,  60901,  United States
Indiana
      Northeast Indiana Research, Fort Wayne,  Indiana,  46825,  United States
      Urology of Indiana, LLC, Indianapolis,  Indiana,  46202,  United States
      Welborn Clinic East, Evansville,  Indiana,  47713,  United States
Iowa
      Urological Associates, PC, Davenport,  Iowa,  52807,  United States
Maryland
      206 Research Associates, Greenbelt,  Maryland,  20770,  United States
Michigan
      Lawrenceville Urology, St. Joseph,  Michigan,  49085,  United States
Missouri
      Saint Louis Urological Surgeons, Inc, St. Louis,  Missouri,  63136,  United States
      Kansas City Urology Care, Kansas City,  Missouri,  64111,  United States
Nevada
      Sheldon J. Freedman, MD, LTD, Las Vegas,  Nevada,  89109,  United States
      Nevada Urology Associates, Reno,  Nevada,  89511,  United States
New Jersey
      Associated Urologic Specialists, PA, Marlton,  New Jersey,  08053,  United States
      Lawrenceville Urology, Lawrenceville,  New Jersey,  08648,  United States
      Urological Surgical Associates, Edison,  New Jersey,  08837,  United States
New York
      Center for Urologic Research of Western New York, Williamsville,  New York,  14221,  United States
      Hudson Valley Urology, Poughkeepsie,  New York,  12601,  United States
      Urological Surgeons of Long Island, Garden City,  New York,  11530,  United States
      Suffolk Urology Associates, Bay Shore,  New York,  11706,  United States
North Carolina
      Northeast Urology Research, Concord,  North Carolina,  28025,  United States
Ohio
      The Urology Group, Cincinnati,  Ohio,  45212,  United States
Rhode Island
      University Urological Research Institute, Providence,  Rhode Island,  02906,  United States
South Carolina
      Grand Strand Urology, Myrtle Beach,  South Carolina,  29572,  United States
Tennessee
      Vanderbilt Medical Center Dept of Urologic Surgery, Nashville,  Tennessee,  37232,  United States
Texas
      Urology San Antonio Research, San Antonio,  Texas,  78229,  United States
      Urology Specialists & Associates, Dallas,  Texas,  75231,  United States
      Urology Associates of North Texas, Fort Worth,  Texas,  76104,  United States
Utah
      Salt Lake Research, Salt Lake City,  Utah,  84124,  United States
Virginia
      Devine-Tidewater Urology, Virginia Beach,  Virginia,  23454,  United States
Washington
      Madigan Army Medical Center, Tacoma,  Washington,  98431,  United States

Study ID Numbers:  C02-008
Record last reviewed:  April 2005
Last Updated:  April 5, 2005
Record first received:  March 20, 2003
ClinicalTrials.gov Identifier:  NCT00056654
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08