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

Prostatic Neoplasms Clinical Trial

Official title:

Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056654
• Other study ID #: C02-008
• Status: Completed
• Phase: N/A
• First received: March 20, 2003
• Last updated: September 16, 2008
• Start date: March 2003
• Est. completion date: July 2004

Study information

• Verified date: September 2008
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Leuprolide acetate
45 mg Intramuscular injection 6 month depot formulation

Locations

Country	Name	City	State
United States	Alaska Clinical Research Center, LLC	Anchorage	Alaska
United States	Emory University	Atlanta	Georgia
United States	Georgia Urology, PA	Atlanta	Georgia
United States	Urology Research Options	Aurora	Colorado
United States	South Florida Medical Research	Aventura	Florida
United States	Suffolk Urology Associates	Bay Shore	New York
United States	West Side Veteran Administration Medical Center	Chicago	Illinois
United States	The Urology Group	Cincinnati	Ohio
United States	Northeast Urology Research	Concord	North Carolina
United States	Urology Specialists & Associates	Dallas	Texas
United States	Urological Associates, PC	Davenport	Iowa
United States	Atlantic Urological Associates	Daytona Beach	Florida
United States	Urological Surgical Associates	Edison	New Jersey
United States	Los Angeles Clinical Research Center	Encino	California
United States	Pacific Clinical Center	Encino	California
United States	Welborn Clinic East	Evansville	Indiana
United States	Northeast Indiana Research	Fort Wayne	Indiana
United States	Urology Associates of North Texas	Fort Worth	Texas
United States	Urology Associates of Central California	Fresno	California
United States	Urological Surgeons of Long Island	Garden City	New York
United States	206 Research Associates	Greenbelt	Maryland
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	Urology of Indiana, LLC	Indianapolis	Indiana
United States	UroSearch	Inverness	Florida
United States	Kankakee Urological Associates	Kankakee	Illinois
United States	Kansas City Urology Care	Kansas City	Missouri
United States	Center for Urologic Research	La Mesa	California
United States	South Orange County Medical Research Center	Laguna Woods	California
United States	Sheldon J. Freedman, MD, LTD	Las Vegas	Nevada
United States	Lawrenceville Urology	Lawrenceville	New Jersey
United States	Arkansas Urology	Little Rock	Arkansas
United States	Associated Urologic Specialists, PA	Marlton	New Jersey
United States	Grand Strand Urology	Myrtle Beach	South Carolina
United States	Vanderbilt Medical Center Dept of Urologic Surgery	Nashville	Tennessee
United States	Advanced Research Institute	New Port Richey	Florida
United States	Atlantic Urological Associates	New Smyrna Beach	Florida
United States	Florida Foundation for Healthcare Research	Ocala	Florida
United States	UroSearch	Ocala	Florida
United States	Atlantic Urological Associates	Orange City	Florida
United States	Specialty Care Research	Peoria	Illinois
United States	Hudson Valley Urology	Poughkeepsie	New York
United States	University Urological Research Institute	Providence	Rhode Island
United States	Nevada Urology Associates	Reno	Nevada
United States	Salt Lake Research	Salt Lake City	Utah
United States	Urology San Antonio Research	San Antonio	Texas
United States	San Diego Uro-Research	San Diego	California
United States	Lawrenceville Urology	St Joseph	Michigan
United States	Saint Louis Urological Surgeons, Inc	St Louis	Missouri
United States	Atlantic Urological Associates	St. Augustine	Florida
United States	Madigan Army Medical Center	Tacoma	Washington
United States	Western Clinical Research	Torrance	California
United States	Devine-Tidewater Urology	Virginia Beach	Virginia
United States	Connecticut Clinical Research Center	Waterbury	Connecticut
United States	Center for Urologic Research of Western New York	Williamsville	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change from baseline in prostate specific antigen (PSA).		Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit	No
Secondary	Change from baseline in prostatic acid phosphatase (PAP).		Weeks 1, 12, 26, 40, 52 and Final Visit	No