Clinical trial NCT00116779: A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer
Official title: An Open-label, Randomized, Multi-center, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer Dosed for Thirteen 28-day Cycles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Androgen ablation therapy
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-07-01
Enrollment: 127
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 the study was to contribute, along with other such dose-finding studies, to the identification of the most effective treatment regimen for a one month depot injection of degarelix in the treatment of prostate cancer by a rapid and sustained suppression of testosterone.


Eligibility criteria: Inclusion Criteria:

Each patient must meet the following inclusion criteria before entry into the study.

* Has given written consent prior to any study-related activity is performed (a study-related activity is defined as any procedure that would not have been performed during the normal management of the patient).
* Histologically confirmed adenocarcinoma of the prostate (all stages), in whom endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This includes patients with rising PSA after having received radical prostatectomy (removal of the entire prostate and seminal vesicles) or radiotherapy with curative intention.
* Male patient aged 18 years or over.
* Has a baseline testosterone above the lower limit of normal range.
* Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2.
* Has a PSA value of greater than or equal to 2ng/mL.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be entered into the study.

* Previous or present hormonal management of prostate cancer (surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens, estrogens). However, patients having undergone neoadjuvant hormonal therapy in conjunction with prostatectomy or radiotherapy with curative intention may be included so long as the hormonal therapy did not exceed a total duration of 6 months and was terminated at least 6 months prior to the Screening Visit.
* Currently or recently (within the last 12 weeks preceding the Screening Visit) under treatment with any other drug modifying testosterone level or function.
* Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 6 months from Screening Visit.
* Has a history of severe asthma (defined as a need for daily treatment with oral or inhalation steroids to control the asthma), anaphylactic reactions, angioedema, angioneurotic edema or Quincke's Edema.
* Has hypersensitivity towards any component of the investigational products (degarelix or mannitol).
* Has history of other cancer within the last 5 years except for prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
* Has elevated serum ALT level more than three times above upper level of normal range or serum total bilirubin level above one and a half times above upper level of normal range as measured by the laboratory at the Screening Visit.
* Has known or suspect hepatic disease of any sort. Patients with liver disease are not to be enrolled in this study.
* Has other clinically significant laboratory abnormalities, which in the judgment of the investigator would interfere with the participation of the patient in this study or evaluation of study results.
* Has a clinically significant disorder (other than prostate cancer) or any other condition, including excessive alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator.
* Has a mental incapacity or language barriers precluding adequate understanding or cooperation.
* Has received an investigational drug within the last 12 weeks preceding Screening Visit.
* Has previously participated in any degarelix study

Primary outcomes:
measure: Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364
timeFrame: Day 28 to Day 364
measure: Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28
timeFrame: Day 28 - Day 364
Secondary outcomes:
measure: Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.
timeFrame: Day 3
measure: Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen
timeFrame: Day 0 (post dose) to Day 364
measure: Days to Prostate-Specific Antigen Progression
timeFrame: Day 0 (post dose) to Day 364
measure: Median Di-Hydrotestosterone Levels At Various Study Timepoints
timeFrame: Baseline, Days 1, 3, 7, 14
measure: Median Prostate-Specific Antigen Values at Various Study Timepoints
timeFrame: Baseline, Days 3, 14, 28, 84, 364
measure: Median Luteinizing Hormone Levels at Various Study Timeframes
timeFrame: Baseline, Days 1, 3, 7, 14
measure: Median Testosterone Levels at Various Days During the Study
timeFrame: Baseline, Days 1,3,7,14,364
measure: Number of Participants With Abnormal Alanine Aminotransferase Values
timeFrame: Day 1 through day 364
measure: Number of Participants With Abnormal Aspartate Aminotransferase Values
timeFrame: Day 1 - 364
measure: Number of Participants With Abnormal Total Bilirubin Values
timeFrame: Day 1 - 364
measure: Participants With Markedly Abnormal Changes in Vital Signs or Body Weight
timeFrame: Day 364
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: Anchorage
country: United States
facility: Alaska Clinical Research Center, LLC
state: Alaska
city: Anaheim
country: United States
facility: Advanced Urology Medical Center
state: California
city: Laguna Woods,
country: United States
facility: South Orange County Medical Research Cnter
state: California
city: Santa Monica
country: United States
facility: Pacific Clinical Research
state: California
city: Tarzana
country: United States
facility: West Coast Clinical Research
state: California
city: Torrance
country: United States
facility: Western Clinical Research
state: California
city: Denver
country: United States
facility: Urology Associate PC
state: Colorado
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Fort Myers
country: United States
facility: SW Florida Urological Associates
state: Florida
city: Ocala
country: United States
facility: Florida Foundation for Healthcare Research
state: Florida
city: Melrose Park
country: United States
facility: RMD Clinical Reseach Institution LLC
state: Illinois
city: Fort Wayne
country: United States
facility: Northeast Indiana Research, LLC
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Reno
country: United States
facility: Nevada Urology Associates
state: Nevada
city: Lawrenceville
country: United States
facility: Lawrenceville Urology
state: New Jersey
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology PC
state: New York
city: Greensboro
country: United States
facility: The Urology Center
state: North Carolina
city: State College
country: United States
facility: State College Urologic Association
state: Pennsylvania
city: Providence
country: United States
facility: Univeristy Urological Research Institute
state: Rhode Island
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: South Burlington
country: United States
facility: University of Vermont, Dept of Surgery
state: Vermont
city: Richmond
country: United States
facility: Virginia Urology Center
state: Virginia
city: Seattle
country: United States
facility: Office of Jeffrey Frankel
state: Washington
city: Cheyenne
country: United States
facility: Wyoming Research Foundation
state: Wyoming
city: Kelowna
country: Canada
facility: Southern Interior Medical Research Corporation
state: British Columbia
city: Surrey
country: Canada
facility: Dr. Cal Abdreau Research
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Research, Inc.
state: British Columbia
city: Victoria
country: Canada
facility: Dr. Gary Steinhoff Clinical Research
state: British Columbia
city: Kentville
country: Canada
facility: Valley Professional Center
state: Nova Scotia
city: Barrie
country: Canada
facility: The Male and Female Health and Research Centers
state: Ontario
city: Brantford
country: Canada
facility: Brantford Urology Research
state: Ontario
city: Burlington
country: Canada
facility: Burlington Professional Care
state: Ontario
city: Oakville
country: Canada
facility: The Female/Male Health Centres
state: Ontario
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
citation: Gittelman M, Pommerville PJ, Persson BE, Jensen JK, Olesen TK; Degarelix Study Group. A 1-year, open label, randomized phase II dose finding study of degarelix for the treatment of prostate cancer in North America. J Urol. 2008 Nov;180(5):1986-92. doi: 10.1016/j.juro.2008.07.033. Epub 2008 Sep 17.