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Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00819156
First received: January 7, 2009
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

The purpose of the trial was to evaluate the safety and efficacy of degarelix when comparing six different doses. The patients participating in the trial were treated with degarelix every month for a year. During the treatment the patients had to visit the clinic for investigations. Blood samples for testosterone, dihydrotestosterone, luteinizing hormone, follicle stimulating hormone, and Prostate Specific Antigen were taken and analysed throughout the trial.


Condition Intervention Phase
Prostate Cancer
Drug: degarelix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomised, Multi-centre, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Six Different Dosing Regimens in Patients With Prostate Cancer Treated for 12 Months

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of patients who achieved a testosterone level considered a castration level.


Secondary Outcome Measures:
  • Number of Patients With Testosterone Level <=0.5 Nanogram/Milliliter From Day 28 to Day 364 for Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28 [ Time Frame: Day 28 - 364 ] [ Designated as safety issue: No ]
    Number of patients who maintained a castration level of testosterone (<=0.5 Nanogram/Milliliter) while on a maintenance dose of Degarelix from Day 28 - 364.

  • Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.

  • Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3. [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
    The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.

  • Days to 50 Percent Reduction in Prostate-Specific Antigen [ Time Frame: Day 0 (post dose) to Day 364 ] [ Designated as safety issue: No ]
    Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.

  • Days to 90 Percent Reduction in Prostate-Specific Antigen [ Time Frame: Day 0 (post dose) to Day 364 ] [ Designated as safety issue: No ]
    Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.

  • Days to Prostate-Specific Antigen Progression [ Time Frame: Day 0 (post dose) to Day 364 ] [ Designated as safety issue: No ]
    Median days to prostate-specific antigen increase of >= 50 percent and >=5 nanograms/milliliter compared to nadir on two consecutive visits at least two weeks apart.

  • Median Serum Testosterone Levels [ Time Frame: Day 0 (Baseline), Days 1,3,7,14, and 364 ] [ Designated as safety issue: No ]
  • Median Prostate-specific Antigen Levels [ Time Frame: Day 0 (Baseline), Days 3, 7, 14, and 364 ] [ Designated as safety issue: No ]
  • Median Values of Di-Hydrotestosterone [ Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364 ] [ Designated as safety issue: No ]
  • Median Values for Serum Luteinizing Hormone [ Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364 ] [ Designated as safety issue: No ]
  • Median Values for Follicle Stimulation Hormone [ Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364 ] [ Designated as safety issue: No ]
  • The Number of Patients With Abnormal Liver Function Tests [ Time Frame: 364 days ] [ Designated as safety issue: No ]
    The number of patients who had abnormal (defined as above upper limit of normal range(ULN)) alanine aminotransferase(ALT), aspartate aminotransferase levels, and bilirubin levels. Also includes the number of patients who had ALT increases >3x ULN, and patients with ALT increases >3x ULN with concurrent increases in bilirubin >1.5 ULN.

  • The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight [ Time Frame: Day 364 ] [ Designated as safety issue: No ]
    Vital sign and body weight values at the end of the trial are compared to baseline values. The table represents the number of patients in each group with normal baseline values and markedly abnormal end-of-study values.


Enrollment: 189
Study Start Date: February 2004
Study Completion Date: September 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix 200/80
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix was given as subcutaneous injections.
Other Name: FE200486
Experimental: Degarelix 200/120
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix was given as subcutaneous injections.
Other Name: FE200486
Experimental: Degarelix 200/160
Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix was given as subcutaneous injections.
Other Name: FE200486
Experimental: Degarelix 240/80
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix was given as subcutaneous injections.
Other Name: FE200486
Experimental: Degarelix 240/120
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix was given as subcutaneous injections.
Other Name: FE200486
Experimental: Degarelix 240/160
Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintenance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Drug: degarelix
Degarelix was given as subcutaneous injections.
Other Name: FE200486

Detailed Description:

Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent prior to any study related procedures
  • Proven prostate cancer in need for endocrine treatment, except for neoadjuvant hormonal therapy, but including patients with a rising PSA further to prostatectomy or radiotherapy
  • ECOG score to be equal to or above 2
  • Testosterone level within age-specific normal range
  • PSA value equal to or above 2 ng/ml
  • Life expectancy of at least 6 months

Exclusion Criteria:

  • Previous or current hormonal treatment of prostate cancer
  • Recent or current treatment with any drugs modifying the testosterone level
  • Candidate for curative treatment such as prostatectomy or radiotherapy
  • History of severe asthma, anaphylactic reactions, angioedema, angioneurotic oedema or Quincke's Oedema
  • Hypersensitivity towards any component of degarelix or mannitol
  • Cancer disease within the last 5 years except for prostate cancer and some skin cancers
  • Signs of liver impairment shown as elevated serum ALT or serum bilirubin
  • Known hepatic disease
  • Other laboratory abnormalities that judged by the investigator would interfere with the patients participation in the trial or the evaluation of the trial results
  • Clinically significant disorder including excessive alcohol or drug abuse that may interfere with trial participation or influence the conclusion of the trial as judged by the investigator
  • Mental incapacity or language barrier precluding adequate understanding or cooperation
  • Having received an investigational product within the last 12 weeks preceding the trial
  • Previous participation in this trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819156

  Show 39 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Publications:
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00819156     History of Changes
Other Study ID Numbers: FE200486 CS12
Study First Received: January 7, 2009
Results First Received: January 22, 2009
Last Updated: December 20, 2011
Health Authority: Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
Romania: Ministry of Public Health
Romania: National Medicines Agency
Hungary: National Institute of Pharmacy
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: Independent Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
South Africa: Department of Health
South Africa: Human Research Ethics Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014