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

Completed · Not applicable

Conditions studied: Prostatic Neoplasms

In brief

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.

Key facts

Study ID

NCT00056654

Run by

Abbott

People needed

164

Starts

2003-03-01

Expected to finish

2004-07-01

Last updated by the study team

2008-09-17

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• Medical Affiliated Research Center — Huntsville, Alabama, United States
• Alaska Clinical Research Center, LLC — Anchorage, Alaska, United States
• Arkansas Urology — Little Rock, Arkansas, United States
• Pacific Clinical Center — Encino, California, United States
• Los Angeles Clinical Research Center — Encino, California, United States
• Urology Associates of Central California — Fresno, California, United States
• Center for Urologic Research — La Mesa, California, United States
• South Orange County Medical Research Center — Laguna Woods, California, United States
• San Diego Uro-Research — San Diego, California, United States
• Western Clinical Research — Torrance, California, United States
• Urology Research Options — Aurora, Colorado, United States
• Connecticut Clinical Research Center — Waterbury, Connecticut, United States
• South Florida Medical Research — Aventura, Florida, United States
• Atlantic Urological Associates — Daytona Beach, Florida, United States
• UroSearch — Inverness, Florida, United States
• Advanced Research Institute — New Port Richey, Florida, United States
• Atlantic Urological Associates — New Smyrna Beach, Florida, United States
• UroSearch — Ocala, Florida, United States
• Florida Foundation for Healthcare Research — Ocala, Florida, United States
• Atlantic Urological Associates — Orange City, Florida, United States
• Atlantic Urological Associates — Saint Augustine, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Georgia Urology, PA — Atlanta, Georgia, United States
• West Side Veteran Administration Medical Center — Chicago, Illinois, United States
• Urology Centers of Alabama — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.