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

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00056654

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

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Leuprolide Leuprolide acetate

U.S. FDA Resources

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
1: Experimental	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

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:	Abbott ( Peter Bacher, Global Project Head )
Study ID Numbers:	C02-008
Study First Received:	March 20, 2003
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00056654 History of Changes
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:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Reproductive Control Agents
Genital Diseases, Male

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Leuprolide
Therapeutic Uses
Fertility Agents, Female
Fertility Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009