A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00116779
• Other study ID #: FE200486 CS14
• Status: Completed
• Phase: Phase 2
• First received: June 30, 2005
• Last updated: December 15, 2011
• Start date: February 2004
• Est. completion date: August 2005

Study information

• Verified date: December 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix
Drug supplied as a powder to be dissolved in the solvent for solution for injection. Maintenance dose given in twelve 28-day cycles.

Locations

Country	Name	City	State
Canada	The Male and Female Health and Research Centers	Barrie	Ontario
Canada	Brantford Urology Research	Brantford	Ontario
Canada	Burlington Professional Care	Burlington	Ontario
Canada	Southern Interior Medical Research Corporation	Kelowna	British Columbia
Canada	Valley Professional Center	Kentville	Nova Scotia
Canada	The Female/Male Health Centres	Oakville	Ontario
Canada	Dr. Cal Abdreau Research	Surrey	British Columbia
Canada	Can-Med Clinical Research, Inc.	Victoria	British Columbia
Canada	Dr. Gary Steinhoff Clinical Research	Victoria	British Columbia
United States	Advanced Urology Medical Center	Anaheim	California
United States	Alaska Clinical Research Center, LLC	Anchorage	Alaska
United States	South Florida Medical Research	Aventura	Florida
United States	Wyoming Research Foundation	Cheyenne	Wyoming
United States	Urology Associate PC	Denver	Colorado
United States	SW Florida Urological Associates	Fort Myers	Florida
United States	Northeast Indiana Research, LLC	Fort Wayne	Indiana
United States	The Urology Center	Greensboro	North Carolina
United States	Urology Centers of Alabama	Homewood	Alabama
United States	South Orange County Medical Research Cnter	Laguna Woods,	California
United States	Lawrenceville Urology	Lawrenceville	New Jersey
United States	RMD Clinical Reseach Institution LLC	Melrose Park	Illinois
United States	Florida Foundation for Healthcare Research	Ocala	Florida
United States	Hudson Valley Urology PC	Poughkeepsie	New York
United States	Univeristy Urological Research Institute	Providence	Rhode Island
United States	Nevada Urology Associates	Reno	Nevada
United States	Virginia Urology Center	Richmond	Virginia
United States	Urology San Antonio Research	San Antonio	Texas
United States	Pacific Clinical Research	Santa Monica	California
United States	Office of Jeffrey Frankel	Seattle	Washington
United States	Regional Urology	Shreveport	Louisiana
United States	University of Vermont, Dept of Surgery	South Burlington	Vermont
United States	State College Urologic Association	State College	Pennsylvania
United States	West Coast Clinical Research	Tarzana	California
United States	Scott & White Memorial Hospital	Temple	Texas
United States	Western Clinical Research	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364	Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364	Day 28 to Day 364	No
Primary	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	Number of participants who maintained a testosterone level of <=0.5 nanogram/milliliter from Day 28 to Day 364.	Day 28 - Day 364	No
Secondary	Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.	Testosterone levels checked at Day 3 to determine if the reduction in testosterone level occurs rapidly after dosing.	Day 3	No
Secondary	Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen	Median number of days after the first dose of Degarelix when the Prostate-Specific Antigen levels fell to 50 percent and 90 percent of the baseline value.	Day 0 (post dose) to Day 364	No
Secondary	Days to Prostate-Specific Antigen Progression	Median days to prostate-specific antigen increase of >= 50 percent and >= 5 nanograms/milliliter compared to nadir on two consecutive visits at least 2 weeks apart.	Day 0 (post dose) to Day 364	No
Secondary	Median Di-Hydrotestosterone Levels At Various Study Timepoints	Di-hydrotestosterone levels at baseline and days 1, 3, 7, 14	Baseline, Days 1, 3, 7, 14	No
Secondary	Median Prostate-Specific Antigen Values at Various Study Timepoints	Prostate-specific antigen levels at baseline and days 3, 14, 28, 84, and 364.	Baseline, Days 3, 14, 28, 84, 364	No
Secondary	Median Luteinizing Hormone Levels at Various Study Timeframes	Luteinizing hormone levels at baseline, and days 1, 3, 7, and 14.	Baseline, Days 1, 3, 7, 14	No
Secondary	Median Testosterone Levels at Various Days During the Study	Testosterone levels at baseline and days 1, 3, 7, 14 and 364	Baseline, Days 1,3,7,14,364	No
Secondary	Number of Participants With Abnormal Alanine Aminotransferase Values	Participants whose alanine aminotransferase values were at levels above the normal range.	Day 1 through day 364	No
Secondary	Number of Participants With Abnormal Aspartate Aminotransferase Values	Participants with aspartate aminotransferase values that were above the normal range.	Day 1 - 364	No
Secondary	Number of Participants With Abnormal Total Bilirubin Values	Participants with abnormal total bilirubin values	Day 1 - 364	No
Secondary	Participants With Markedly Abnormal Changes in Vital Signs or Body Weight	Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of participants in each group with normal baseline values and markedly abnormal end-of-study values.	Day 364	No