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

September 16, 2008 updated by: Abbott

Pharmacokinetic, Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
164

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Urology Centers of Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Clinical Research Center, LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Urology
    • California
      • Encino, California, United States, 91316
        • Pacific Clinical Center
      • Encino, California, United States, 91416
        • Los Angeles Clinical Research Center
      • Fresno, California, United States, 93720
        • Urology Associates of Central California
      • La Mesa, California, United States, 91942
        • Center for Urologic Research
      • Laguna Woods, California, United States, 92653
        • South Orange County Medical Research Center
      • San Diego, California, United States, 92101
        • San Diego Uro-Research
      • Torrance, California, United States, 90505
        • Western Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Urology Research Options
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Connecticut Clinical Research Center
    • Florida
      • Aventura, Florida, United States, 33180
        • South Florida Medical Research
      • Daytona Beach, Florida, United States, 32114
        • Atlantic Urological Associates
      • Inverness, Florida, United States, 34452
        • UroSearch
      • New Port Richey, Florida, United States, 34652
        • Advanced Research Institute
      • New Smyrna Beach, Florida, United States, 32168
        • Atlantic Urological Associates
      • Ocala, Florida, United States, 34474
        • Florida Foundation for Healthcare Research
      • Ocala, Florida, United States, 34470
        • UroSearch
      • Orange City, Florida, United States, 32763
        • Atlantic Urological Associates
      • St. Augustine, Florida, United States, 32086
        • Atlantic Urological Associates
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30342
        • Georgia Urology, PA
    • Illinois
      • Chicago, Illinois, United States, 60602
        • West Side Veteran Administration Medical Center
      • Kankakee, Illinois, United States, 60901
        • Kankakee Urological Associates
      • Peoria, Illinois, United States, 61614
        • Specialty Care Research
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Welborn Clinic East
      • Fort Wayne, Indiana, United States, 46825
        • Northeast Indiana Research
      • Indianapolis, Indiana, United States, 46202
        • Urology of Indiana, LLC
    • Iowa
      • Davenport, Iowa, United States, 52807
        • Urological Associates, PC
    • Maryland
      • Greenbelt, Maryland, United States, 20770
        • 206 Research Associates
    • Michigan
      • St Joseph, Michigan, United States, 49085
        • Lawrenceville Urology
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City Urology Care
      • St Louis, Missouri, United States, 63136
        • Saint Louis Urological Surgeons, Inc
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Sheldon J. Freedman, MD, LTD
      • Reno, Nevada, United States, 89511
        • Nevada Urology Associates
    • New Jersey
      • Edison, New Jersey, United States, 08837
        • Urological Surgical Associates
      • Lawrenceville, New Jersey, United States, 08648
        • Lawrenceville Urology
      • Marlton, New Jersey, United States, 08053
        • Associated Urologic Specialists, PA
    • New York
      • Bay Shore, New York, United States, 11706
        • Suffolk Urology Associates
      • Garden City, New York, United States, 11530
        • Urological Surgeons of Long Island
      • Poughkeepsie, New York, United States, 12601
        • Hudson Valley Urology
      • Williamsville, New York, United States, 14221
        • Center for Urologic Research of Western New York
    • North Carolina
      • Concord, North Carolina, United States, 28025
        • Northeast Urology Research
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • The Urology Group
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • University Urological Research Institute
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Grand Strand Urology
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Medical Center Dept of Urologic Surgery
    • Texas
      • Dallas, Texas, United States, 75231
        • Urology Specialists & Associates
      • Fort Worth, Texas, United States, 76104
        • Urology Associates of North Texas
      • San Antonio, Texas, United States, 78229
        • Urology San Antonio Research
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Salt Lake Research
    • Virginia
      • Virginia Beach, Virginia, United States, 23454
        • Devine-Tidewater Urology
    • Washington
      • Tacoma, Washington, United States, 98431
        • Madigan Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 1
Drug: Leuprolide acetate
45 mg Intramuscular injection 6 month depot formulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Day 32 through Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and Final Visit
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
Weeks 1, 4, 8, 12, 16, 20, 24, 26, 27, 28, 30, 32, 36, 40, 44, 48, 52 and Final Visit
Change from baseline in prostate specific antigen (PSA).
Time Frame: Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit
Weeks 1, 12, 26, 27, 30, 40, 52 and Final Visit
Change from baseline in prostatic acid phosphatase (PAP).
Time Frame: Weeks 1, 12, 26, 40, 52 and Final Visit
Weeks 1, 12, 26, 40, 52 and Final Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2003

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2004

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2003

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C02-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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