Prostate Cancer Clinical Trial
Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
Summary
The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma.
Full Description
The primary purpose of the study is to determine if a new sustained-release 45 mg (depot) formulation of leuprolide acetate administered once every 26 weeks for 1 year, will lower testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma. This study will also evaluate the pharmacokinetic profile of the 45 mg formulation and assess the safety of this formulation.
Eligibility Criteria
Inclusion Criteria:
Histological diagnosis of prostate cancer
Need for androgen deprivation treatment for 1 year
Serum testosterone level ≥ 150 ng/dL
Life expectancy of at least 18 months
ECOG Performance status grades 0,1 or 2
Exclusion Criteria:
Hypersensitivity to leuprolide acetate or polylactic acid
History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
History of hypogonadism
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There are 55 Locations for this study
Homewood Alabama, 35209, United States
Huntsville Alabama, 35801, United States
Anchorage Alaska, 99508, United States
Little Rock Arkansas, 72211, United States
Encino California, 91316, United States
Encino California, 91416, United States
Fresno California, 93720, United States
La Mesa California, 91942, United States
Laguna Woods California, 92653, United States
San Diego California, 92101, United States
Torrance California, 90505, United States
Aurora Colorado, 80012, United States
Waterbury Connecticut, 06708, United States
Aventura Florida, 33180, United States
Daytona Beach Florida, 32114, United States
Inverness Florida, 34452, United States
New Port Richey Florida, 34652, United States
New Smyrna Beach Florida, 32168, United States
Ocala Florida, 34470, United States
Ocala Florida, 34474, United States
Orange City Florida, 32763, United States
St. Augustine Florida, 32086, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Chicago Illinois, 60602, United States
Kankakee Illinois, 60901, United States
Peoria Illinois, 61614, United States
Evansville Indiana, 47713, United States
Fort Wayne Indiana, 46825, United States
Indianapolis Indiana, 46202, United States
Davenport Iowa, 52807, United States
Greenbelt Maryland, 20770, United States
St Joseph Michigan, 49085, United States
Kansas City Missouri, 64111, United States
St Louis Missouri, 63136, United States
Las Vegas Nevada, 89109, United States
Reno Nevada, 89511, United States
Edison New Jersey, 08837, United States
Lawrenceville New Jersey, 08648, United States
Marlton New Jersey, 08053, United States
Bay Shore New York, 11706, United States
Garden City New York, 11530, United States
Poughkeepsie New York, 12601, United States
Williamsville New York, 14221, United States
Concord North Carolina, 28025, United States
Cincinnati Ohio, 45212, United States
Providence Rhode Island, 02906, United States
Myrtle Beach South Carolina, 29572, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75231, United States
Fort Worth Texas, 76104, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84124, United States
Virginia Beach Virginia, 23454, United States
Tacoma Washington, 98431, United States
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