A Study of Degarelix in Patients With Prostate Cancer

NCT00928434 | Completed Phase 3 Results

• 1 other identifier: FE200486 CS37
• Study Type: interventional
• Target: 409
• Locations: 1 country
• Sites: 59

Brief Summary

The purpose of this study was to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) would show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL

  Percentage of patients with serum PSA levels ≤4.0 ng/mL at 14 month was presented.

  At 14 month

Secondary Outcomes (19)

• Absolute Change From Baseline in Serum PSA Levels

  Phase A Visit 1-8 and Phase B Visit 9-15.

• Percent Change From Baseline in Serum PSA Levels

  Phase A Visit 1-8 and Phase B Visit 9-15.

• Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being

  During 14 months

• Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being

  During 14 months

• Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being

  During 14 months

Study Arms (3)

DI (Degarelix Intermittent)

EXPERIMENTAL

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered. During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.

Drug: Degarelix

DC (Degarelix Continuous)

EXPERIMENTAL

Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall

Drug: Degarelix

LC (Leuprolide Continuous)

ACTIVE COMPARATOR

Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions. One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer's labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively). On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.

Drug: Leuprolide

Interventions

Degarelix DRUG

Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period.

DI (Degarelix Intermittent)

Leuprolide DRUG

Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)

LC (Leuprolide Continuous)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older.
• Raising PSA after prior treatment failure of localized prostate cancer.
• Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded) based on the most current biopsy.
• Has a screening testosterone within normal range (≥1.5 ng/mL).
• Has Eastern Cooperative Oncology Group score of ≤2.
• Bone scan or CT scan report documenting no evidence of metastasis to the bone or internal organs.
• Life expectancy of at least 15 months.

You may not qualify if:

• Taken hormone therapy in the last 6 months prior to entering this study.
• Being treated with 5-alpha reductase inhibitor at time of enrolment and remained on a stable dose throughout the trial.
• Has a history of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
• Has hypersensitivity towards any component of the study drug.
• Has a previous history or presence of another malignancy other than prostate cancer or treated squamous/basal cell carcinoma of the skin within the last five years.
• Has abnormal laboratory results which in the judgement of the Investigator would affect the patient's health or the outcome of the trial.
• Has a clinically significant medical condition (other than prostate cancer) including but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.
• Has an intellectual incapacity or language barriers precluding adequate understanding or co-operation.
• Has received an investigational drug within the last 28 days before the Screening visit or longer if considered to possibly influence the outcome of the current trial.
• Has received ketoconazole or diflucan in the last 28 days preceding the Screening Visit.
• Has previously participated in any Degarelix trial.
• Is part of an ongoing trial.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (59)

Alabama Clinical Research, Inc

Alexander City, Alabama, United States

Location

Urology Center of Alabama, PC

Homewood, Alabama, United States

Location

Advanced Urology Medical Center

Anaheim, California, United States

Location

Peninsula Urology Medical Center

Atherton, California, United States

Location

Urology Associates of Central California

Fresno, California, United States

Location

South Orange County Medical Research Center

Laguna Hills, California, United States

Location

Atlantic Urology Medical Group

Long Beach, California, United States

Location

San Bernardino Urological Associates

San Bernardino, California, United States

Location

San Diego Uro-Research

San Diego, California, United States

Location

Santa Barbara Clinical Research

Santa Barbara, California, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, United States

Location

The Urology Center of Colorado

Denver, Colorado, United States

Location

Urology Associates Research

Englewood, Colorado, United States

Location

Connecticut Clinical Research Center

Middlebury, Connecticut, United States

Location

Grove Hill Medical Center

New Britain, Connecticut, United States

Location

Walter Reed Army Hospital Medical Center

Washington D.C., District of Columbia, United States

Location

South Florida Medical Research

Aventura, Florida, United States

Location

Urology Health Solutions, Inc

Celebration, Florida, United States

Location

Florida Urology Physicians

Fort Myers, Florida, United States

Location

University of Florida

Gainesville, Florida, United States

Location

Winter Park Urology Associates

Orlando, Florida, United States

Location

Southeastern Urology Center, PA

Tallahassee, Florida, United States

Location

Tampa Bay Urology

Tampa, Florida, United States

Location

Advanced Research Institute, Inc

Trinity, Florida, United States

Location

Urology Enterprises

Marietta, Georgia, United States

Location

Midwest Urology/RMD Clinical Research Institute

Melrose Park, Illinois, United States

Location

Deaconess Clinic Inc

Evansville, Indiana, United States

Location

Northeast Indiana Research

Fort Wayne, Indiana, United States

Location

Metropolitan Urology, PSC

Jeffersonville, Indiana, United States

Location

Regional Urology, Lic

Shreveport, Louisiana, United States

Location

Chesapeake Urology Associates

Baltimore, Maryland, United States

Location

Chesapeake Urology Research Associates

Baltimore, Maryland, United States

Location

Chesapeake Urology Research Associates

Glen Burnie, Maryland, United States

Location

Myron Murdock M.D. LLC

Greenbelt, Maryland, United States

Location

Chesapeake Urology Associates, PA

Towson, Maryland, United States

Location

Urology Associates of Englewood

Englewood, New Jersey, United States

Location

Hamilton Urology PA

Hamilton, New Jersey, United States

Location

Lawrenceville Urology

Lawrenceville, New Jersey, United States

Location

Nationsmed Clinical Research

Perth Amboy, New Jersey, United States

Location

Center for Urologic Care

Voorhees Township, New Jersey, United States

Location

Delaware Valley Urology LLC

Woodlane, New Jersey, United States

Location

The Urological Institute of NE NY, CCP

Albany, New York, United States

Location

Medical & Clinical Research Associates

Bay Shore, New York, United States

Location

Brooklyn Heights Urology Associates, P.C.

Brooklyn, New York, United States

Location

University Urology Associates

New York, New York, United States

Location

Hudson Valley Urology P.C.

Poughkeepsie, New York, United States

Location

Northeast Urology Research

Concord, North Carolina, United States

Location

Alliance Urology Specialists

Greensboro, North Carolina, United States

Location

Urological Association of Lancaster

Lancaster, Pennsylvania, United States

Location

State College Urologic Association

State College, Pennsylvania, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Location

Lexington Urological Associates, PA

West Columbia, South Carolina, United States

Location

Urology Associates

Nashville, Tennessee, United States

Location

Lackland Air Force base

San Antonio, Texas, United States

Location

Urology of Virginia

Norfolk, Virginia, United States

Location

Virginal Urology

Richmond, Virginia, United States

Location

Virginia Urology Center

Richmond, Virginia, United States

Location

Seattle Urology Research Center

Seattle, Washington, United States

Location

Roger D. Fincher, PS

Spokane, Washington, United States

Location

Related Publications (1)

• Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

  PMID: 34350976 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Clinical Development Support
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: May 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 13, 2016
• Results First Posted: December 13, 2016

Record last verified: 2016-10

Locations

US (59)