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Study of a 6-Month Sustained-release Formulation of Leuprolide in Prostate Cancer



Study of a 6-Month Sustained-release Formulation of Leuprolide in Prostate Cancer

For Condition: Prostatic Neoplasms
Status: No longer recruiting
Sponsor(s): TAP Pharmaceutical Products ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: - Histological diagnosis of prostate cancer - Need for androgen deprivation treatment for 1 year - Discontinuation from other prostate cancer treatments
Total Enrollment: 

Location and Contact Information:

Florida Foundation for Healthcare Research
Ocala,  Florida,  34474
United States
 

206 Research Associates
Greenbelt,  Maryland,  20770
United States
 

Medical Affiliated Research Center
Huntsville,  Alabama,  35801
United States
 

Los Angeles Clinical Research Center
Encino,  California,  91416
United States
 

Lawrenceville Urology
Lawrenceville,  New Jersey,  08648
United States
 

Urological Surgeons of Long Island
Garden City,  New York,  11530
United States
 

Center for Urologic Research
La Mesa,  California,  91942
United States
 

Urological Associates, PC
Davenport,  Iowa,  52807
United States
 

Kankakee Urological Associates
Kankakee,  Illinois,  60901
United States
 

Vanderbilt Medical Center Dept of Urologic Surgery
Nashville,  Tennessee,  37232
United States
 

Georgia Urology, PA
Atlanta,  Georgia,  30342
United States
 

UroSearch
Inverness,  Florida,  34452
United States
 

Alaska Clinical Research Center, LLC
Anchorage,  Alaska,  99508
United States
 

Center for Urologic Research of Western New York
Williamsville,  New York,  14221
United States
 

University Urological Research Institute
Providence,  Rhode Island,  02906
United States
 

West Side Veteran Administration Medical Center
Chicago,  Illinois,  60602
United States
 

Advanced Research Institute
New Port Richey,  Florida,  34652
United States
 

Atlantic Urological Associates
St. Augustine,  Florida,  32086
United States
 

Sheldon J. Freedman, MD, LTD
Las Vegas,  Nevada,  89109
United States
 

Emory University
Atlanta,  Georgia,  30322
United States
 

Lawrenceville Urology
St. Joseph,  Michigan,  49085
United States
 

Salt Lake Research
Salt Lake City,  Utah,  84124
United States
 

Hudson Valley Urology
Poughkeepsie,  New York,  12601
United States
 

Madigan Army Medical Center
Tacoma,  Washington,  98431
United States
 

South Orange County Medical Research Center
Laguna Woods,  California,  92653
United States
 

Urology Research Options
Aurora,  Colorado,  80012
United States
 

Associated Urologic Specialists, PA
Marlton,  New Jersey,  08053
United States
 

Urology Specialists & Associates
Dallas,  Texas,  75231
United States
 

Urology Associates of North Texas
Ft. Worth,  Texas,  76104
United States
 

Atlantic Urological Associates
New Smyrna Beach,  Florida,  32168
United States
 

Devine-Tidewater Urology
Virginia Beach,  Virginia,  23454
United States
 

Nevada Urology Associates
Reno,  Nevada,  89511
United States
 

Northeast Indiana Research
Ft. Wayne,  Indiana,  46825
United States
 

Atlantic Urological Associates
Orange City,  Florida,  32763
United States
 

Urological Surgical Associates
Edison,  New Jersey,  08837
United States
 

Grand Strand Urology
Myrtle Beach,  South Carolina,  29572
United States
 

Atlantic Urological Associates
Daytona Beach,  Florida,  32114
United States
 

Specialty Care Research
Peoria,  Illinois,  61614
United States
 

Welborn Clinic East
Evansville,  Indiana,  47713
United States
 

Urology Associates of Central California
Fresno,  California,  93720
United States
 

Urology San Antonio Research
San Antonio,  Texas,  78229
United States
 

Northeast Urology Research
Concord,  North Carolina,  28025
United States
 

Urology Centers of Alabama
Homewood,  Alabama,  35209
United States
 

Kansas City Urology Care
Kansas City,  Missouri,  64111
United States
 

Saint Louis Urological Surgeons, Inc
St. Louis,  Missouri,  63136
United States
 

Western Clinical Research
Torrance,  California,  90505
United States
 

UroSearch
Ocala,  Florida,  34470
United States
 

Urology of Indiana, LLC
Indianapolis,  Indiana,  46202
United States
 

Connecticut Clinical Research Center
Waterbury,  Connecticut,  06708
United States
 

Suffolk Urology Associates
Bay Shore,  New York,  11706
United States
 

San Diego Uro-Research
San Diego,  California,  92101
United States
 

The Urology Group
Cincinnati,  Ohio,  45212
United States
 

Pacific Clinical Center
Encino,  California,  91316
United States
 

Visions Clinical Research
Palm Springs,  Florida,  33461
United States
 

Arkansas Urology
Little Rock,  Arkansas,  72211
United States
 

South Florida Medical Research
Aventura,  Florida,  33180
United States
 


Additional Information:
Study ID Numbers:
  C02-008; 
Study Start Date: March 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056654

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4. YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy

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Study of a 6-Month Sustained-release Formulation of Leuprolide in Prostate Cancer

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