search
Back to results

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

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Leuprolide acetate
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Leuprolide, Prostatic Neoplasms, Testosterone, Prostate-specific Antigen, Pharmacokinetics, luprolide acetate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Urology Centers of Alabama
  • Medical Affiliated Research Center
  • Alaska Clinical Research Center, LLC
  • Arkansas Urology
  • Pacific Clinical Center
  • Los Angeles Clinical Research Center
  • Urology Associates of Central California
  • Center for Urologic Research
  • South Orange County Medical Research Center
  • San Diego Uro-Research
  • Western Clinical Research
  • Urology Research Options
  • Connecticut Clinical Research Center
  • South Florida Medical Research
  • Atlantic Urological Associates
  • UroSearch
  • Advanced Research Institute
  • Atlantic Urological Associates
  • UroSearch
  • Florida Foundation for Healthcare Research
  • Atlantic Urological Associates
  • Atlantic Urological Associates
  • Emory University
  • Georgia Urology, PA
  • West Side Veteran Administration Medical Center
  • Kankakee Urological Associates
  • Specialty Care Research
  • Welborn Clinic East
  • Northeast Indiana Research
  • Urology of Indiana, LLC
  • Urological Associates, PC
  • 206 Research Associates
  • Lawrenceville Urology
  • Kansas City Urology Care
  • Saint Louis Urological Surgeons, Inc
  • Sheldon J. Freedman, MD, LTD
  • Nevada Urology Associates
  • Urological Surgical Associates
  • Lawrenceville Urology
  • Associated Urologic Specialists, PA
  • Suffolk Urology Associates
  • Urological Surgeons of Long Island
  • Hudson Valley Urology
  • Center for Urologic Research of Western New York
  • Northeast Urology Research
  • The Urology Group
  • University Urological Research Institute
  • Grand Strand Urology
  • Vanderbilt Medical Center Dept of Urologic Surgery
  • Urology Specialists & Associates
  • Urology Associates of North Texas
  • Urology San Antonio Research
  • Salt Lake Research
  • Devine-Tidewater Urology
  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Suppression of serum testosterone (<=50 ng/dL) and maintenance of serum testosterone suppression once suppression is achieved for individual subjects.

Secondary Outcome Measures

Change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status.
Change from baseline in symptom severity (bone pain, pain on urination, urination difficulty).
Change from baseline in prostate specific antigen (PSA).
Change from baseline in prostatic acid phosphatase (PAP).

Full Information

First Posted
March 20, 2003
Last Updated
September 16, 2008
Sponsor
Abbott
search

1. Study Identification

Unique Protocol Identification Number
NCT00056654
Brief Title
Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
Official Title
Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Leuprolide, Prostatic Neoplasms, Testosterone, Prostate-specific Antigen, Pharmacokinetics, luprolide acetate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Leuprolide acetate
Intervention Description
45 mg Intramuscular injection 6 month depot formulation
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
Change from baseline in prostate specific antigen (PSA).
Time Frame
Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit
Title
Change from baseline in prostatic acid phosphatase (PAP).
Time Frame
Weeks 1, 12, 26, 40, 52 and Final Visit

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Urology Centers of Alabama
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Medical Affiliated Research Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Alaska Clinical Research Center, LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Arkansas Urology
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Pacific Clinical Center
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Los Angeles Clinical Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91416
Country
United States
Facility Name
Urology Associates of Central California
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Center for Urologic Research
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
South Orange County Medical Research Center
City
Laguna Woods
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
San Diego Uro-Research
City
San Diego
State/Province
California
ZIP/Postal Code
92101
Country
United States
Facility Name
Western Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Urology Research Options
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Connecticut Clinical Research Center
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Atlantic Urological Associates
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
UroSearch
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Advanced Research Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Atlantic Urological Associates
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
UroSearch
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Facility Name
Florida Foundation for Healthcare Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Atlantic Urological Associates
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Atlantic Urological Associates
City
St. Augustine
State/Province
Florida
ZIP/Postal Code
32086
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Georgia Urology, PA
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
West Side Veteran Administration Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Kankakee Urological Associates
City
Kankakee
State/Province
Illinois
ZIP/Postal Code
60901
Country
United States
Facility Name
Specialty Care Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
Welborn Clinic East
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Northeast Indiana Research
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Urology of Indiana, LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Urological Associates, PC
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
206 Research Associates
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Lawrenceville Urology
City
St Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Kansas City Urology Care
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Louis Urological Surgeons, Inc
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Facility Name
Sheldon J. Freedman, MD, LTD
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Nevada Urology Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Urological Surgical Associates
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Lawrenceville Urology
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Associated Urologic Specialists, PA
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Suffolk Urology Associates
City
Bay Shore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
Urological Surgeons of Long Island
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Hudson Valley Urology
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Center for Urologic Research of Western New York
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Northeast Urology Research
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
University Urological Research Institute
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Grand Strand Urology
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Vanderbilt Medical Center Dept of Urologic Surgery
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Urology Specialists & Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Urology Associates of North Texas
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Urology San Antonio Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Salt Lake Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Devine-Tidewater Urology
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs