Clinical trial NCT00928434: A Study of Degarelix in Patients With Prostate Cancer
Official title: A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-06-26
Enrollment: 409
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Patients With Serum PSA Levels ≤4.0 ng/mL
timeFrame: At 14 month
Secondary outcomes:
measure: Absolute Change From Baseline in Serum PSA Levels
timeFrame: Phase A Visit 1-8 and Phase B Visit 9-15.
measure: Percent Change From Baseline in Serum PSA Levels
timeFrame: Phase A Visit 1-8 and Phase B Visit 9-15.
measure: Change From Baseline in Quality of Life as Assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) : Physical Well-being
timeFrame: During 14 months
measure: Change From Baseline in Quality of Life as Assessed by the FACT-P : Emotional Well-being
timeFrame: During 14 months
measure: Change From Baseline in Quality of Life as Assessed by the FACT-P : Social Well-being
timeFrame: During 14 months
measure: Change From Baseline in Quality of Life as Assessed by the FACT-P : Functional Well-being
timeFrame: During 14 months
measure: Change From Baseline in Quality of Life as Assessed by the FACT-P : Additional Concerns
timeFrame: During 14 months
measure: Change From Baseline in Quality of Life as Assessed by the FACT-P: Total FACT-P Score
timeFrame: During 14 months
measure: Change From Baseline in Sexual Function as Assessed by the Sexual Function Index (SFI): Sexual Drive
timeFrame: During 14 months
measure: Change From Baseline in Sexual Function as Assessed by the SFI: Erection
timeFrame: During 14 months
measure: Change From Baseline in Sexual Function as Assessed by the SFI: Ejaculation
timeFrame: During 14 months
measure: Change From Baseline in Sexual Function as Assessed by the SFI: Problem Assessment
timeFrame: During 14 months
measure: Change From Baseline in Sexual Function as Assessed by the SFI: Overall Satisfaction With Sex Life
timeFrame: During 14 months
measure: Change From Baseline in Sexual Function as Assessed by the SFI: Total SFI Score
timeFrame: During 14 months
measure: Percentage of Subjects With a Serum PSA Level ≤4.0 ng/mL
timeFrame: At 14 months
measure: Time to Return to Testosterone >0.5 ng/mL Level in the DI Treatment Group
timeFrame: During Phase B
measure: Time to Return to Normal Range (≥1.5 ng/mL) or Baseline Testosterone Level
timeFrame: During Phase B
measure: Absolute Change From Baseline in Serum Testosterone Levels
timeFrame: Phase A Visit 1-8 and Phase B Visit 9-15.
measure: Percent Change From Baseline in Serum Testosterone Levels
timeFrame: Phase A Visit 1-8 and Phase B Visit 9-15.
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Alabama Clinical Research, Inc
state: Alabama
city: Homewood
country: United States
facility: Urology Center of Alabama, PC
state: Alabama
city: Anaheim
country: United States
facility: Advanced Urology Medical Center
state: California
city: Atherton
country: United States
facility: Peninsula Urology Medical Center
state: California
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: Laguna Hills
country: United States
facility: South Orange County Medical Research Center
state: California
city: Long Beach
country: United States
facility: Atlantic Urology Medical Group
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: San Diego
country: United States
facility: San Diego Uro-Research
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Clinical Research
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Denver
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Englewood
country: United States
facility: Urology Associates Research
state: Colorado
city: Middlebury
country: United States
facility: Connecticut Clinical Research Center
state: Connecticut
city: New Britain
country: United States
facility: Grove Hill Medical Center
state: Connecticut
city: Washington
country: United States
facility: Walter Reed Army Hospital Medical Center
state: District of Columbia
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Celebration
country: United States
facility: Urology Health Solutions, Inc
state: Florida
city: Fort Myers
country: United States
facility: Florida Urology Physicians
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Orlando
country: United States
facility: Winter Park Urology Associates
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Urology Center, PA
state: Florida
city: Tampa
country: United States
facility: Tampa Bay Urology
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute, Inc
state: Florida
city: Marietta
country: United States
facility: Urology Enterprises
state: Georgia
city: Melrose Park
country: United States
facility: Midwest Urology/RMD Clinical Research Institute
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Inc
state: Indiana
city: Fort Wayne
country: United States
facility: Northeast Indiana Research
state: Indiana
city: Jeffersonville
country: United States
facility: Metropolitan Urology, PSC
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology, Lic
state: Louisiana
city: Baltimore
country: United States
facility: Chesapeake Urology Associates
state: Maryland
city: Baltimore
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Glen Burnie
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Greenbelt
country: United States
facility: Myron Murdock M.D. LLC
state: Maryland
city: Towson
country: United States
facility: Chesapeake Urology Associates, PA
state: Maryland
city: Englewood
country: United States
facility: Urology Associates of Englewood
state: New Jersey
city: Hamilton
country: United States
facility: Hamilton Urology PA
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Perth Amboy
country: United States
facility: Nationsmed Clinical Research
state: New Jersey
city: Voorhees
country: United States
facility: Center for Urologic Care
state: New Jersey
city: Westampton
country: United States
facility: Delaware Valley Urology LLC
state: New Jersey
city: Albany
country: United States
facility: The Urological Institute of NE NY, CCP
state: New York
city: Bay Shore
country: United States
facility: Medical & Clinical Research Associates
state: New York
city: Brooklyn
country: United States
facility: Brooklyn Heights Urology Associates, P.C.
state: New York
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology P.C.
state: New York
city: Concord
country: United States
facility: Northeast Urology Research
state: North Carolina
city: Greensboro
country: United States
facility: Alliance Urology Specialists
state: North Carolina
city: Lancaster
country: United States
facility: Urological Association of Lancaster
state: Pennsylvania
city: State College
country: United States
facility: State College Urologic Association
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: West Columbia
country: United States
facility: Lexington Urological Associates, PA
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates
state: Tennessee
city: San Antonio
country: United States
facility: Lackland Air Force base
state: Texas
city: Norfolk
country: United States
facility: Urology of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginal Urology
state: Virginia
city: Richmond
country: United States
facility: Virginia Urology Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Urology Research Center
state: Washington
city: Spokane
country: United States
facility: Roger D. Fincher, PS
state: Washington
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: 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.