Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00056654

Purpose

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.

Condition	Intervention
Prostatic Neoplasms	Drug: Leuprolide acetate

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Leuprolide Leuprolide acetate

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects. [ Time Frame: Day 32 through Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status. [ Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit ] [ Designated as safety issue: No ]
Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty). [ Time Frame: Weeks 1, 4, 8, 12, 16, 20, 24, 26, 27, 28, 30, 32, 36, 40, 44, 48, 52 and Final Visit ] [ Designated as safety issue: No ]
Change from baseline in prostate specific antigen (PSA). [ Time Frame: Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit ] [ Designated as safety issue: No ]
Change from baseline in prostatic acid phosphatase (PAP). [ Time Frame: Weeks 1, 12, 26, 40, 52 and Final Visit ] [ Designated as safety issue: No ]

Enrollment:	164
Study Start Date:	March 2003
Study Completion Date:	July 2004
Primary Completion Date:	July 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Leuprolide acetate 45 mg Intramuscular injection 6 month depot formulation

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056654

Hide Study Locations

Locations

United States, Alabama
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
United States, Arkansas
Arkansas Urology
Little Rock, Arkansas, United States, 72211
United States, California
Center for Urologic Research
La Mesa, California, United States, 91942
San Diego Uro-Research
San Diego, California, United States, 92101
South Orange County Medical Research Center
Laguna Woods, California, United States, 92653
Los Angeles Clinical Research Center
Encino, California, United States, 91416
Urology Associates of Central California
Fresno, California, United States, 93720
Pacific Clinical Center
Encino, California, United States, 91316
Western Clinical Research
Torrance, California, United States, 90505
United States, Colorado
Urology Research Options
Aurora, Colorado, United States, 80012
United States, Connecticut
Connecticut Clinical Research Center
Waterbury, Connecticut, United States, 06708
United States, Florida
Florida Foundation for Healthcare Research
Ocala, Florida, United States, 34474
Advanced Research Institute
New Port Richey, Florida, United States, 34652
South Florida Medical Research
Aventura, Florida, United States, 33180
UroSearch
Inverness, Florida, United States, 34452
Atlantic Urological Associates
Orange City, Florida, United States, 32763
Atlantic Urological Associates
St. Augustine, Florida, United States, 32086
Atlantic Urological Associates
Daytona Beach, Florida, United States, 32114
UroSearch
Ocala, Florida, United States, 34470
Atlantic Urological Associates
New Smyrna Beach, Florida, United States, 32168
United States, Georgia
Georgia Urology, PA
Atlanta, Georgia, United States, 30342
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Kankakee Urological Associates
Kankakee, Illinois, United States, 60901
West Side Veteran Administration Medical Center
Chicago, Illinois, United States, 60602
Specialty Care Research
Peoria, Illinois, United States, 61614
United States, Indiana
Northeast Indiana Research
Fort Wayne, Indiana, United States, 46825
Urology of Indiana, LLC
Indianapolis, Indiana, United States, 46202
Welborn Clinic East
Evansville, Indiana, United States, 47713
United States, Iowa
Urological Associates, PC
Davenport, Iowa, United States, 52807
United States, Maryland
206 Research Associates
Greenbelt, Maryland, United States, 20770
United States, Michigan
Lawrenceville Urology
St Joseph, Michigan, United States, 49085
United States, Missouri
Saint Louis Urological Surgeons, Inc
St Louis, Missouri, United States, 63136
Kansas City Urology Care
Kansas City, Missouri, United States, 64111
United States, Nevada
Sheldon J. Freedman, MD, LTD
Las Vegas, Nevada, United States, 89109
Nevada Urology Associates
Reno, Nevada, United States, 89511
United States, New Jersey
Associated Urologic Specialists, PA
Marlton, New Jersey, United States, 08053
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
Urological Surgical Associates
Edison, New Jersey, United States, 08837
United States, New York
Center for Urologic Research of Western New York
Williamsville, New York, United States, 14221
Hudson Valley Urology
Poughkeepsie, New York, United States, 12601
Urological Surgeons of Long Island
Garden City, New York, United States, 11530
Suffolk Urology Associates
Bay Shore, New York, United States, 11706
United States, North Carolina
Northeast Urology Research
Concord, North Carolina, United States, 28025
United States, Ohio
The Urology Group
Cincinnati, Ohio, United States, 45212
United States, Rhode Island
University Urological Research Institute
Providence, Rhode Island, United States, 02906
United States, South Carolina
Grand Strand Urology
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Vanderbilt Medical Center Dept of Urologic Surgery
Nashville, Tennessee, United States, 37232
United States, Texas
Urology San Antonio Research
San Antonio, Texas, United States, 78229
Urology Specialists & Associates
Dallas, Texas, United States, 75231
Urology Associates of North Texas
Fort Worth, Texas, United States, 76104
United States, Utah
Salt Lake Research
Salt Lake City, Utah, United States, 84124
United States, Virginia
Devine-Tidewater Urology
Virginia Beach, Virginia, United States, 23454
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Peter Bacher, Global Project Head )
Study ID Numbers:	C02-008
Study First Received:	March 20, 2003
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00056654 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

Leuprolide
Prostatic Neoplasms
Testosterone

Prostate-specific Antigen
Pharmacokinetics
luprolide acetate

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Leuprolide
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009