Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
- Registration Number
- NCT00056654
- Lead Sponsor
- Abbott
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 164
- 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
- Hypersensitivity to leuprolide acetate or polylactic acid
- History of bilateral orchiectomy, adrenalectomy, or hypophysectomy
- History of hypogonadism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Leuprolide acetate -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 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 Change from baseline in prostate specific antigen (PSA). Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit Change from baseline in prostatic acid phosphatase (PAP). Weeks 1, 12, 26, 40, 52 and Final Visit
Trial Locations
- Locations (50)
Urology Centers of Alabama
🇺🇸Homewood, Alabama, United States
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
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