Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients With Prostate Cancer Requiring Androgen Ablation Therapy - Full Text View

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00468286

Purpose

The study will have two treatment groups, evaluating two Degarelix doses. First dose is the initial dose followed by a maintenance dose given every three months. The initial dose given to suppress the testosterone level and the three month maintenance dose to maintain the suppressed testosterone level over one year of treatment.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Degarelix Powder and Solvent for Suspension for Injection

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

- To establish the degarelix dosing regimen that most effectively achieves and maintain testosterone suppression at at castrate levels during one year of treatment. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
To evaluate degarelix pharmacokinetics. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
To compare safety and tolerability profiles of different three-month dosing regimens. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment:	134
Study Start Date:	May 2007
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.	Drug: Degarelix : Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months. Drug: Degarelix Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
B: Experimental Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.	Drug: Degarelix Experimental Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.

Detailed Description:

An Open-Label, Multi-Centre, Randomized Parallel-Group Dose-Finding Study, Investigating Efficacy and Safety of Two Degarelix Three-Month Dosing Regimens in Patients with Prostrate Cancer Requiring Androgen Ablation Therapy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion / Exclusion Criteria:

Patients, aged 18 years or older, with histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
Screening testosterone level above the lower limit of normal range, globally defined as >2.2 ng/mL.
ECOG score of ≤2.
Screening PSA level ≥ ng/mL.

Primary endpoint:

- Probability of testosterone at castration level (≤05., ng/mL) from Day 28 through Day 364.

Secondary endpoints:

Probability of testosterone at castration level (≤05. ng/mL) from Day 56 through Day 364.
Serum levels of testosterone, PSA, LH, and FSH over time.
Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
Plasma levels of degarelix over time.
Frequency and severity of adverse events.
Clinically significant changes in laboratory safety parameters.
Clinically significant changes in physical examinations, electrocardiograms (ECGs), vital signs, and body weight.
Life expectancy of at least one year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468286

Locations

United States, Alabama
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
United States, California
South Orange County Medical Research Center
Laguna Woods, California, United States, 92653
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Florida Foundation for Healthcare Research
Ocala, Florida, United States, 34474
United States, Louisiana
Regional Urology
Shreveport, Louisiana, United States, 71106
United States, New Jersey
Lawrenceville Urology
Lawrenceville, New Jersey, United States, 08648
United States, New York
Jay A. Motola, MD, FACS
Carmel, New York, United States, 10512
United States, North Carolina
The Urology Center
Greensboro, North Carolina, United States, 27403
North Urology Research
Concord, North Carolina, United States, 28025
United States, Pennsylvania
State College Urologic Association
State College, Pennsylvania, United States, 16801
United States, South Carolina
Grand Strand Urology
Myrtle Beach, South Carolina, United States, 29572
United States, Virginia
Urology of Virginia Research
Norfolk, Virginia, United States, 23502
United States, Washington
Office of Jeffrey Frankel
Seattle, Washington, United States, 98166

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Weiying Gong, MD & MS

Ferring Pharmaceutical Inc.

More Information

Study ID Numbers:	FE 200486 CS18
Study First Received:	April 13, 2007
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00468286
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:

Prostate Cancer.

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009