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

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.

Study Type: Interventional

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

Study Primary Completion Date: July 2004

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.
  • Time Frame: Day 32 through Week 52
    Safety Issue?: No

Secondary Measures

• Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
  • Time Frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit
    Safety Issue?: No
• Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty).
  • Time Frame: Weeks 1, 4, 8, 12, 16, 20, 24, 26, 27, 28, 30, 32, 36, 40, 44, 48, 52 and Final Visit
    Safety Issue?: No
• Change from baseline in prostate specific antigen (PSA).
  • Time Frame: Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit
    Safety Issue?: No
• Change from baseline in prostatic acid phosphatase (PAP).
  • Time Frame: Weeks 1, 12, 26, 40, 52 and Final Visit
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Abbott

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00056654

Study ID Number: C02-008

ClinicalTrials.gov Identifier: NCT00056654

Health Authority: United States: Food and Drug Administration