Clinical trial NCT00056654: Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
Official title: Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Leuprolide
Prostatic Neoplasms
Testosterone
Prostate-specific Antigen
Pharmacokinetics
luprolide acetate
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-03-21
Enrollment: 164
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.
timeFrame: Day 32 through Week 52
Secondary outcomes:
measure: Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit
measure: Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty).
timeFrame: Weeks 1, 4, 8, 12, 16, 20, 24, 26, 27, 28, 30, 32, 36, 40, 44, 48, 52 and Final Visit
measure: Change from baseline in prostate specific antigen (PSA).
timeFrame: Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit
measure: Change from baseline in prostatic acid phosphatase (PAP).
timeFrame: Weeks 1, 12, 26, 40, 52 and Final Visit
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, LLC
state: Alaska
city: Little Rock
country: United States
facility: Arkansas Urology
state: Arkansas
city: Encino
country: United States
facility: Pacific Clinical Center
state: California
city: Encino
country: United States
facility: Los Angeles Clinical Research Center
state: California
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: La Mesa
country: United States
facility: Center for Urologic Research
state: California
city: Laguna Woods
country: United States
facility: South Orange County Medical Research Center
state: California
city: San Diego
country: United States
facility: San Diego Uro-Research
state: California
city: Torrance
country: United States
facility: Western Clinical Research
state: California
city: Aurora
country: United States
facility: Urology Research Options
state: Colorado
city: Waterbury
country: United States
facility: Connecticut Clinical Research Center
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Daytona Beach
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Inverness
country: United States
facility: UroSearch
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute
state: Florida
city: New Smyrna Beach
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Ocala
country: United States
facility: UroSearch
state: Florida
city: Ocala
country: United States
facility: Florida Foundation for Healthcare Research
state: Florida
city: Orange City
country: United States
facility: Atlantic Urological Associates
state: Florida
city: St. Augustine
country: United States
facility: Atlantic Urological Associates
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Georgia Urology, PA
state: Georgia
city: Chicago
country: United States
facility: West Side Veteran Administration Medical Center
state: Illinois
city: Kankakee
country: United States
facility: Kankakee Urological Associates
state: Illinois
city: Peoria
country: United States
facility: Specialty Care Research
state: Illinois
city: Evansville
country: United States
facility: Welborn Clinic East
state: Indiana
city: Fort Wayne
country: United States
facility: Northeast Indiana Research
state: Indiana
city: Indianapolis
country: United States
facility: Urology of Indiana, LLC
state: Indiana
city: Davenport
country: United States
facility: Urological Associates, PC
state: Iowa
city: Greenbelt
country: United States
facility: 206 Research Associates
state: Maryland
city: St Joseph
country: United States
facility: Lawrenceville Urology
state: Michigan
city: Kansas City
country: United States
facility: Kansas City Urology Care
state: Missouri
city: St Louis
country: United States
facility: Saint Louis Urological Surgeons, Inc
state: Missouri
city: Las Vegas
country: United States
facility: Sheldon J. Freedman, MD, LTD
state: Nevada
city: Reno
country: United States
facility: Nevada Urology Associates
state: Nevada
city: Edison
country: United States
facility: Urological Surgical Associates
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Marlton
country: United States
facility: Associated Urologic Specialists, PA
state: New Jersey
city: Bay Shore
country: United States
facility: Suffolk Urology Associates
state: New York
city: Garden City
country: United States
facility: Urological Surgeons of Long Island
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology
state: New York
city: Williamsville
country: United States
facility: Center for Urologic Research of Western New York
state: New York
city: Concord
country: United States
facility: Northeast Urology Research
state: North Carolina
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Providence
country: United States
facility: University Urological Research Institute
state: Rhode Island
city: Myrtle Beach
country: United States
facility: Grand Strand Urology
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Medical Center Dept of Urologic Surgery
state: Tennessee
city: Dallas
country: United States
facility: Urology Specialists & Associates
state: Texas
city: Fort Worth
country: United States
facility: Urology Associates of North Texas
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Research
state: Utah
city: Virginia Beach
country: United States
facility: Devine-Tidewater Urology
state: Virginia
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References: