Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
1 other identifier
interventional
164
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2003
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 20, 2003
CompletedFirst Posted
Study publicly available on registry
March 21, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedSeptember 17, 2008
September 1, 2008
1.3 years
March 20, 2003
September 16, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hypersensitivity to leuprolide acetate or polylactic acid
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- History of hypogonadism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (55)
Urology Centers of Alabama
Homewood, Alabama, 35209, United States
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
Alaska Clinical Research Center, LLC
Anchorage, Alaska, 99508, United States
Arkansas Urology
Little Rock, Arkansas, 72211, United States
Pacific Clinical Center
Encino, California, 91316, United States
Los Angeles Clinical Research Center
Encino, California, 91416, United States
Urology Associates of Central California
Fresno, California, 93720, United States
Center for Urologic Research
La Mesa, California, 91942, United States
South Orange County Medical Research Center
Laguna Woods, California, 92653, United States
San Diego Uro-Research
San Diego, California, 92101, United States
Western Clinical Research
Torrance, California, 90505, United States
Urology Research Options
Aurora, Colorado, 80012, United States
Connecticut Clinical Research Center
Waterbury, Connecticut, 06708, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Atlantic Urological Associates
Daytona Beach, Florida, 32114, United States
UroSearch
Inverness, Florida, 34452, United States
Advanced Research Institute
New Port Richey, Florida, 34652, United States
Atlantic Urological Associates
New Smyrna Beach, Florida, 32168, United States
UroSearch
Ocala, Florida, 34470, United States
Florida Foundation for Healthcare Research
Ocala, Florida, 34474, United States
Atlantic Urological Associates
Orange City, Florida, 32763, United States
Atlantic Urological Associates
Saint Augustine, Florida, 32086, United States
Emory University
Atlanta, Georgia, 30322, United States
Georgia Urology, PA
Atlanta, Georgia, 30342, United States
West Side Veteran Administration Medical Center
Chicago, Illinois, 60602, United States
Kankakee Urological Associates
Kankakee, Illinois, 60901, United States
Specialty Care Research
Peoria, Illinois, 61614, United States
Welborn Clinic East
Evansville, Indiana, 47713, United States
Northeast Indiana Research
Fort Wayne, Indiana, 46825, United States
Urology of Indiana, LLC
Indianapolis, Indiana, 46202, United States
Urological Associates, PC
Davenport, Iowa, 52807, United States
206 Research Associates
Greenbelt, Maryland, 20770, United States
Lawrenceville Urology
Saint Joseph, Michigan, 49085, United States
Kansas City Urology Care
Kansas City, Missouri, 64111, United States
Saint Louis Urological Surgeons, Inc
St Louis, Missouri, 63136, United States
Sheldon J. Freedman, MD, LTD
Las Vegas, Nevada, 89109, United States
Nevada Urology Associates
Reno, Nevada, 89511, United States
Urological Surgical Associates
Edison, New Jersey, 08837, United States
Lawrenceville Urology
Lawrenceville, New Jersey, 08648, United States
Associated Urologic Specialists, PA
Marlton, New Jersey, 08053, United States
Suffolk Urology Associates
Bay Shore, New York, 11706, United States
Urological Surgeons of Long Island
Garden City, New York, 11530, United States
Hudson Valley Urology
Poughkeepsie, New York, 12601, United States
Center for Urologic Research of Western New York
Williamsville, New York, 14221, United States
Northeast Urology Research
Concord, North Carolina, 28025, United States
The Urology Group
Cincinnati, Ohio, 45212, United States
University Urological Research Institute
Providence, Rhode Island, 02906, United States
Grand Strand Urology
Myrtle Beach, South Carolina, 29572, United States
Vanderbilt Medical Center Dept of Urologic Surgery
Nashville, Tennessee, 37232, United States
Urology Specialists & Associates
Dallas, Texas, 75231, United States
Urology Associates of North Texas
Fort Worth, Texas, 76104, United States
Urology San Antonio Research
San Antonio, Texas, 78229, United States
Salt Lake Research
Salt Lake City, Utah, 84124, United States
Devine-Tidewater Urology
Virginia Beach, Virginia, 23454, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 20, 2003
First Posted
March 21, 2003
Study Start
March 1, 2003
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
September 17, 2008
Record last verified: 2008-09