A Study of Degarelix in Patients With Prostate Cancer

NCT ID: NCT00928434

Last Updated: 2016-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 409 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-08-31

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.

Detailed Description

This was an open-label, randomized, parallel-arm, multicenter study to determine if degarelix intermittent therapy was non-inferior to continuous androgen deprivation therapy (combination of treatment groups receiving continuous degarelix and leuprolide therapy, respectively) in maintaining PSA levels at ≤ 4.0 ng/mL at 14 months.

The study consisted of two phases, Phase A and B. During Phase A, patients in the degarelix intermittent and degarelix continuous arms received 7 months of therapy with degarelix one-month depot formulation and patients in the leuprolide continuous arm received leuprolide one-month depot injection (7.5 mg) followed by two 3-month depot (22.5 mg) injections. After 7 months of treatment, patients with a PSA ≤2 ng/mL continued into Phase B.

During Phase B, patients in the degarelix intermittent arm had a 7-month off-treatment period. Patients randomized to the degarelix continuous arm and the leuprolide continuous arm continued to receive degarelix or leuprolide depot as in Phase A for the remainder of the 14 months.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DI (Degarelix Intermittent)

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.

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

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

DC (Degarelix Continuous)

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

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

LC (Leuprolide Continuous)

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.

Group Type: ACTIVE_COMPARATOR

Leuprolide

Intervention Type: DRUG

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

Interventions

Degarelix

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

Intervention Type: DRUG

Degarelix

Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses).

Intervention Type: DRUG

Leuprolide

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

Alabama Clinical Research, Inc

Alexander City, Alabama, United States

Urology Center of Alabama, PC

Homewood, Alabama, United States

Advanced Urology Medical Center

Anaheim, California, United States

Peninsula Urology Medical Center

Atherton, California, United States

Urology Associates of Central California

Fresno, California, United States

South Orange County Medical Research Center

Laguna Hills, California, United States

Atlantic Urology Medical Group

Long Beach, California, United States

San Bernardino Urological Associates

San Bernardino, California, United States

San Diego Uro-Research

San Diego, California, United States

Santa Barbara Clinical Research

Santa Barbara, California, United States

University of Colorado Health Sciences Center

Aurora, Colorado, United States

The Urology Center of Colorado

Denver, Colorado, United States

Urology Associates Research

Englewood, Colorado, United States

Connecticut Clinical Research Center

Middlebury, Connecticut, United States

Grove Hill Medical Center

New Britain, Connecticut, United States

Walter Reed Army Hospital Medical Center

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

South Florida Medical Research

Aventura, Florida, United States

Urology Health Solutions, Inc

Celebration, Florida, United States

Florida Urology Physicians

Fort Myers, Florida, United States

University of Florida

Gainesville, Florida, United States

Winter Park Urology Associates

Orlando, Florida, United States

Southeastern Urology Center, PA

Tallahassee, Florida, United States

Tampa Bay Urology

Tampa, Florida, United States

Advanced Research Institute, Inc

Trinity, Florida, United States

Urology Enterprises

Marietta, Georgia, United States

Midwest Urology/RMD Clinical Research Institute

Melrose Park, Illinois, United States

Deaconess Clinic Inc

Evansville, Indiana, United States

Northeast Indiana Research

Fort Wayne, Indiana, United States

Metropolitan Urology, PSC

Jeffersonville, Indiana, United States

Regional Urology, Lic

Shreveport, Louisiana, United States

Chesapeake Urology Associates

Baltimore, Maryland, United States

Chesapeake Urology Research Associates

Baltimore, Maryland, United States

Chesapeake Urology Research Associates

Glen Burnie, Maryland, United States

Myron Murdock M.D. LLC

Greenbelt, Maryland, United States

Chesapeake Urology Associates, PA

Towson, Maryland, United States

Urology Associates of Englewood

Englewood, New Jersey, United States

Hamilton Urology PA

Hamilton, New Jersey, United States

Lawrenceville Urology

Lawrenceville, New Jersey, United States

Nationsmed Clinical Research

Perth Amboy, New Jersey, United States

Center for Urologic Care

Voorhees Township, New Jersey, United States

Delaware Valley Urology LLC

Woodlane, New Jersey, United States

The Urological Institute of NE NY, CCP

Albany, New York, United States

Medical & Clinical Research Associates

Bay Shore, New York, United States

Brooklyn Heights Urology Associates, P.C.

Brooklyn, New York, United States

University Urology Associates

New York, New York, United States

Hudson Valley Urology P.C.

Poughkeepsie, New York, United States

Northeast Urology Research

Concord, North Carolina, United States

Alliance Urology Specialists

Greensboro, North Carolina, United States

Urological Association of Lancaster

Lancaster, Pennsylvania, United States

State College Urologic Association

State College, Pennsylvania, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Lexington Urological Associates, PA

West Columbia, South Carolina, United States

Urology Associates

Nashville, Tennessee, United States

Lackland Air Force base

San Antonio, Texas, United States

Urology of Virginia

Norfolk, Virginia, United States

Virginal Urology

Richmond, Virginia, United States

Virginia Urology Center

Richmond, Virginia, United States

Seattle Urology Research Center

Seattle, Washington, United States

Roger D. Fincher, PS

Spokane, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34350976 (View on PubMed)

Other Identifiers

FE200486 CS37

Identifier Type: -

Identifier Source: org_study_id