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

Tracking Information
First Received Date ^ICMJE	March 20, 2003
Last Updated Date	September 16, 2008
Start Date ^ICMJE	March 2003
Primary Completion Date	July 2004 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 4, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Suppression and maintenance of serum testosterone once suppression is achieved for individual subjects
Change History	Complete list of historical versions of study NCT00056654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 4, 2008)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Changes in serum PSA and PAP Subject assessment of symptom severity ECOG performance status assessment

Descriptive Information
Brief Title ^ICMJE	Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
Official Title ^ICMJE	Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
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.
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Prostatic Neoplasms
Intervention ^ICMJE	Drug: Leuprolide acetate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	164
Completion Date	July 2004
Primary Completion Date	July 2004 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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	Male
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00056654
Responsible Party	Peter Bacher, Global Project Head, Abbott
Study ID Numbers ^ICMJE	C02-008
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Abbott
Verification Date	September 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP