Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
N/A
N/A
Male
Prostatic Neoplasms
Trial Information
Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.
Outcome Time Frame:
Day 32 through Week 52
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
C02-008
NCT ID:
NCT00056654
Start Date:
March 2003
Completion Date:
July 2004
Related Keywords:
- Prostatic Neoplasms
- Leuprolide
- Prostatic Neoplasms
- Testosterone
- Prostate-specific Antigen
- Pharmacokinetics
- luprolide acetate
- Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
| 206 Research Associates | Greenbelt, Maryland 20770 |
| Urology San Antonio Research | San Antonio, Texas 78229 |
| Atlantic Urological Associates | Daytona Beach, Florida 32114 |
| Urology Associates of North Texas | Arlington, Texas 76015 |
| Medical Affiliated Research Center | Huntsville, Alabama 35801 |
| Emory University | Atlanta, Georgia 30322 |
| South Florida Medical Research | Aventura, Florida 33180 |
| UroSearch | Leesburg, Florida 34748 |
| Urology Research Options | Aurora, Colorado 80012 |
| Connecticut Clinical Research Center | Waterbury, Connecticut 06708-2652 |
| Advanced Research Institute | New Port Richey, Florida 34652 |
| Northeast Indiana Research | Fort Wayne, Indiana 46804-4128 |
| Urology of Indiana, LLC | Indianapolis, Indiana 46202 |
| Alaska Clinical Research Center, LLC | Anchorage, Alaska 99508 |
| Florida Foundation for Healthcare Research | Ocala, Florida 34474 |
| Kansas City Urology Care | Kansas City, Missouri 64131 |
| Urological Surgical Associates | Edison, New Jersey |
| The Urology Group | Cincinnati, Ohio 45212 |
| Grand Strand Urology | Myrtle Beach, South Carolina 29572 |
| Urology Centers Of Alabama | Homewood,, Alabama 35205 |
| South Orange County Medical Research Center | Laguna Hills, California 92653 |
| Nevada Urology Associates | Reno, Nevada 89511 |
| Salt Lake Research | Salt Lake City, Utah 84124 |
| Urology Associates Of Central California | Fresno, California 93720 |
| Lawrenceville Urology | Lawrenceville, New Jersey 08648 |
| University Urological Research Institute | Providence, Rhode Island 02904 |
| San Diego Uro-Research | San Diego, California 92101 |
| Arkansas Urology | Little Rock, Arkansas 72211 |
| Pacific Clinical Center | Encino, California 91316 |
| Los Angeles Clinical Research Center | Encino, California 91416 |
| Center for Urologic Research | La Mesa, California 91942 |
| Western Clinical Research | Torrance, California 90505 |
| Georgia Urology, PA | Atlanta, Georgia 30342 |
| West Side Veteran Administration Medical Center | Chicago, Illinois 60602 |
| Kankakee Urological Associates | Kankakee, Illinois 60901 |
| Specialty Care Research | Peoria, Illinois 61614 |
| Welborn Clinic East | Evansville, Indiana 47713 |
| Urological Associates, PC | Davenport, Iowa 52807 |
| Lawrenceville Urology | St Joseph, Michigan 49085 |
| Saint Louis Urological Surgeons, Inc | St Louis, Missouri 63136 |
| Sheldon J. Freedman, MD, LTD | Las Vegas, Nevada 89109 |
| Associated Urologic Specialists, PA | Marlton, New Jersey 08053 |
| Suffolk Urology Associates | Bay Shore, New York 11706 |
| Urological Surgeons of Long Island | Garden City, New York 11530 |
| Hudson Valley Urology | Poughkeepsie, New York 12601 |
| Center for Urologic Research of Western New York | Williamsville, New York 14221 |
| Northeast Urology Research | Concord, North Carolina 28025 |
| Vanderbilt Medical Center Dept of Urologic Surgery | Nashville, Tennessee 37232 |
| Urology Specialists & Associates | Dallas, Texas 75231 |
| Devine-Tidewater Urology | Virginia Beach, Virginia 23454 |
