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

Condition(s) targeted: Prostatic Neoplasms

Intervention: Leuprolide acetate (Drug)

Phase: N/A

Status: Completed

Sponsored by: TAP Pharmaceutical Products Inc.

Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: TAP Pharmaceutical Products Inc.

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.

Secondary outcome:

Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.

Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty).

Change from baseline in prostate specific antigen (PSA).

Change from baseline in prostatic acid phosphatase (PAP).

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Male.

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

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

Center for Urologic Research, La Mesa, California 91942, United States

San Diego Uro-Research, San Diego, California 92101, United States

South Orange County Medical Research Center, Laguna Woods, California 92653, United States

Los Angeles Clinical Research Center, Encino, California 91416, United States

Urology Associates of Central California, Fresno, California 93720, United States

Pacific Clinical Center, Encino, California 91316, 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

Florida Foundation for Healthcare Research, Ocala, Florida 34474, United States

Advanced Research Institute, New Port Richey, Florida 34652, United States

South Florida Medical Research, Aventura, Florida 33180, United States

UroSearch, Inverness, Florida 34452, United States

Atlantic Urological Associates, Daytona Beach, Florida 32114, United States

Atlantic Urological Associates, St. Augustine, Florida 32086, United States

Atlantic Urological Associates, Orange City, Florida 32763, United States

UroSearch, Ocala, Florida 34470, United States

Atlantic Urological Associates, New Smyrna Beach, Florida 32168, United States

Georgia Urology, PA, Atlanta, Georgia 30342, United States

Emory University, Atlanta, Georgia 30322, United States

Specialty Care Research, Peoria, Illinois 61614, United States

West Side Veteran Administration Medical Center, Chicago, Illinois 60602, United States

Kankakee Urological Associates, Kankakee, Illinois 60901, United States

Northeast Indiana Research, Fort Wayne, Indiana 46825, United States

Urology of Indiana, LLC, Indianapolis, Indiana 46202, United States

Welborn Clinic East, Evansville, Indiana 47713, United States

Urological Associates, PC, Davenport, Iowa 52807, United States

206 Research Associates, Greenbelt, Maryland 20770, United States

Lawrenceville Urology, St Joseph, Michigan 49085, United States

Saint Louis Urological Surgeons, Inc, St Louis, Missouri 63136, United States

Kansas City Urology Care, Kansas City, Missouri 64111, United States

Sheldon J. Freedman, MD, LTD, Las Vegas, Nevada 89109, United States

Nevada Urology Associates, Reno, Nevada 89511, United States

Associated Urologic Specialists, PA, Marlton, New Jersey 08053, United States

Lawrenceville Urology, Lawrenceville, New Jersey 08648, United States

Urological Surgical Associates, Edison, New Jersey 08837, United States

Center for Urologic Research of Western New York, Williamsville, New York 14221, United States

Hudson Valley Urology, Poughkeepsie, New York 12601, United States

Urological Surgeons of Long Island, Garden City, New York 11530, United States

Suffolk Urology Associates, Bay Shore, New York 11706, 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 San Antonio Research, San Antonio, Texas 78229, United States

Urology Specialists & Associates, Dallas, Texas 75231, United States

Urology Associates of North Texas, Fort Worth, Texas 76104, 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

Starting date: March 2003
Ending date: July 2004
Last updated: April 4, 2008