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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00056654
First received: March 20, 2003
Last updated: September 16, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
Prostatic Neoplasms
Drug: Leuprolide acetate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]
  • Change from baseline in prostate specific antigen (PSA). [ Time Frame: Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit ] [ Designated as safety issue: No ]
  • Change from baseline in prostatic acid phosphatase (PAP). [ Time Frame: Weeks 1, 12, 26, 40, 52 and Final Visit ] [ Designated as safety issue: No ]

Enrollment: 164
Study Start Date: March 2003
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Leuprolide acetate
45 mg Intramuscular injection 6 month depot formulation

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056654

  Show 55 Study Locations
Sponsors and Collaborators
Abbott
  More Information

No publications provided

Responsible Party: Peter Bacher, Global Project Head, Abbott
ClinicalTrials.gov Identifier: NCT00056654     History of Changes
Other Study ID Numbers: C02-008
Study First Received: March 20, 2003
Last Updated: September 16, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Leuprolide
Prostatic Neoplasms
Testosterone
Prostate-specific Antigen
Pharmacokinetics
luprolide acetate

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 14, 2014