Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
- Registration Number
- NCT00056654
- Lead Sponsor
- Abbott
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 164
- 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
- Hypersensitivity to leuprolide acetate or polylactic acid
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- History of hypogonadism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Leuprolide acetate -
- Primary Outcome Measures
Name Time Method Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects. Day 32 through Week 52
- Secondary Outcome Measures
Name Time Method Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status. Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty). Weeks 1, 4, 8, 12, 16, 20, 24, 26, 27, 28, 30, 32, 36, 40, 44, 48, 52 and Final Visit Change from baseline in prostate specific antigen (PSA). Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit Change from baseline in prostatic acid phosphatase (PAP). Weeks 1, 12, 26, 40, 52 and Final Visit
Trial Locations
- Locations (50)
Urology Associates of Central California
🇺🇸Fresno, California, United States
San Diego Uro-Research
🇺🇸San Diego, California, United States
West Side Veteran Administration Medical Center
🇺🇸Chicago, Illinois, United States
Western Clinical Research
🇺🇸Torrance, California, United States
Emory University
🇺🇸Atlanta, Georgia, United States
The Urology Group
🇺🇸Cincinnati, Ohio, United States
Georgia Urology, PA
🇺🇸Atlanta, Georgia, United States
Northeast Indiana Research
🇺🇸Fort Wayne, Indiana, United States
Urology of Indiana, LLC
🇺🇸Indianapolis, Indiana, United States
Nevada Urology Associates
🇺🇸Reno, Nevada, United States
Urology Specialists & Associates
🇺🇸Dallas, Texas, United States
Devine-Tidewater Urology
🇺🇸Virginia Beach, Virginia, United States
Vanderbilt Medical Center Dept of Urologic Surgery
🇺🇸Nashville, Tennessee, United States
Urology San Antonio Research
🇺🇸San Antonio, Texas, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Urology Associates of North Texas
🇺🇸Fort Worth, Texas, United States
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Alaska Clinical Research Center, LLC
🇺🇸Anchorage, Alaska, United States
Arkansas Urology
🇺🇸Little Rock, Arkansas, United States
Urology Research Options
🇺🇸Aurora, Colorado, United States
Pacific Clinical Center
🇺🇸Encino, California, United States
South Orange County Medical Research Center
🇺🇸Laguna Woods, California, United States
Los Angeles Clinical Research Center
🇺🇸Encino, California, United States
Center for Urologic Research
🇺🇸La Mesa, California, United States
Florida Foundation for Healthcare Research
🇺🇸Ocala, Florida, United States
Connecticut Clinical Research Center
🇺🇸Waterbury, Connecticut, United States
Advanced Research Institute
🇺🇸New Port Richey, Florida, United States
Atlantic Urological Associates
🇺🇸St. Augustine, Florida, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
UroSearch
🇺🇸Ocala, Florida, United States
Kankakee Urological Associates
🇺🇸Kankakee, Illinois, United States
Specialty Care Research
🇺🇸Peoria, Illinois, United States
Lawrenceville Urology
🇺🇸Lawrenceville, New Jersey, United States
Welborn Clinic East
🇺🇸Evansville, Indiana, United States
Sheldon J. Freedman, MD, LTD
🇺🇸Las Vegas, Nevada, United States
Urological Associates, PC
🇺🇸Davenport, Iowa, United States
Saint Louis Urological Surgeons, Inc
🇺🇸St Louis, Missouri, United States
Associated Urologic Specialists, PA
🇺🇸Marlton, New Jersey, United States
Kansas City Urology Care
🇺🇸Kansas City, Missouri, United States
206 Research Associates
🇺🇸Greenbelt, Maryland, United States
Center for Urologic Research of Western New York
🇺🇸Williamsville, New York, United States
Urological Surgeons of Long Island
🇺🇸Garden City, New York, United States
Urological Surgical Associates
🇺🇸Edison, New Jersey, United States
Suffolk Urology Associates
🇺🇸Bay Shore, New York, United States
Hudson Valley Urology
🇺🇸Poughkeepsie, New York, United States
Northeast Urology Research
🇺🇸Concord, North Carolina, United States
University Urological Research Institute
🇺🇸Providence, Rhode Island, United States
Grand Strand Urology
🇺🇸Myrtle Beach, South Carolina, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States