We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00056654
Recruitment Status : Completed
First Posted : March 21, 2003
Last Update Posted : September 17, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Prostatic Neoplasms Drug: Leuprolide acetate

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2003
Primary Completion Date : July 2004
Study Completion Date : July 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Leuprolide acetate
45 mg Intramuscular injection 6 month depot formulation



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Change from baseline in prostate specific antigen (PSA). [ Time Frame: Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit ]
  4. Change from baseline in prostatic acid phosphatase (PAP). [ Time Frame: Weeks 1, 12, 26, 40, 52 and Final Visit ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056654


  Show 55 Study Locations
Sponsors and Collaborators
Abbott

Responsible Party: Peter Bacher, Global Project Head, Abbott
ClinicalTrials.gov Identifier: NCT00056654     History of Changes
Other Study ID Numbers: C02-008
First Posted: March 21, 2003    Key Record Dates
Last Update Posted: September 17, 2008
Last Verified: September 2008

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

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