- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00819156
Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer
November 8, 2023 updated by: Ferring Pharmaceuticals
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
189
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Brussels, Belgium
- UCL Saint Luc
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Gent, Belgium
- UZ Gent
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Leuven, Belgium
- Uz Gasthuisberg
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Berlin, Germany
- Vivantes Klinikum Am Urban
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Freiburg, Germany
- Loretto Krankenhaus
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Fürth, Germany
- Euromed AG Klinik
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Mannheim, Germany
- Urologische Universitätsklinikum
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Budapest, Hungary
- Bajcsy-Zsilinszky Hospital, Urology
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Budapest, Hungary
- Jahn Ferenc Dél Pesti Hospital, Urology
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Györ, Hungary
- Pez Aladar County Hospital
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Miskolc, Hungary
- BAZ County Hospital
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Szeged, Hungary
- Hospital of Local Gov. Szeged, Urology
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Szolnok, Hungary
- MÁV Hospital, Urology
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Amsterdam, Netherlands
- AMC
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Heerlen, Netherlands
- Atrium MC
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Siedlce, Poland
- Wojewódzki Szpital Specjalisttyczny
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Slupsk, Poland
- Wojewódzki Szpital Specjalisttyczny
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Bucharest, Romania
- Dr. Th Burghele Hospital
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Bucharest, Romania
- CF2 Hospital
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Bucharest, Romania
- Fundeni Hospital
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Bucharest, Romania
- Sf. Ioan Hospital
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Moscow, Russian Federation
- Institute of Urology of MoH
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Moscow, Russian Federation
- Botkin Clinical Hospital
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Moscow, Russian Federation
- City Hospital #1
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Moscow, Russian Federation
- City Hospital #29
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Moscow, Russian Federation
- City Hospital #50
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Moscow, Russian Federation
- City Hospital #60
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St Petersburg, Russian Federation
- City Hospital #26
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St Petersburg, Russian Federation
- "Andros" Urology Clinic
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St Petersburg, Russian Federation
- City Hospital #15
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St Petersburg, Russian Federation
- Military Medical Academy, Urology
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St Petersburg, Russian Federation
- Pavlov Medical School Outpatient
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St Petersburg, Russian Federation
- Pavlov medical School, Urology
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St Petersburg, Russian Federation
- Sct Petersburg State Medical Academy
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Glenwood, Durban, South Africa
- 370 Clarke Road
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Hatfield, Pretoria, South Africa
- Pretoria Urology Hospital
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Parktown, South Africa
- WITS Medical School
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Pietermaritzburg, South Africa
- 401B Medical Centre
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Sunninghill, South Africa
- Sunninghill Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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Degarelix was given as subcutaneous injections.
Other Names:
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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.
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Degarelix was given as subcutaneous injections.
Other Names:
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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.
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Degarelix was given as subcutaneous injections.
Other Names:
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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.
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Degarelix was given as subcutaneous injections.
Other Names:
|
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.
|
Degarelix was given as subcutaneous injections.
Other Names:
|
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.
|
Degarelix was given as subcutaneous injections.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364
Time Frame: 12 months
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Number of patients who achieved a testosterone level considered a castration level.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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Day 28 - 364
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Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.
Time Frame: Day 28
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The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after the initial dose cycle.
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Day 28
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Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.
Time Frame: Day 3
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The number of patients who achieved the <=0.5 nanogram/milliliter level for serum testosterone after 3 days.
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Day 3
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Days to 50 Percent Reduction in Prostate-Specific Antigen
Time Frame: Day 0 (post dose) to Day 364
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Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 50 percent of the baseline value.
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Day 0 (post dose) to Day 364
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Days to 90 Percent Reduction in Prostate-Specific Antigen
Time Frame: Day 0 (post dose) to Day 364
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Median number of days after the first dose of Degarelix when the prostate-specific antigen levels fell to 90 percent of the baseline value.
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Day 0 (post dose) to Day 364
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Days to Prostate-Specific Antigen Progression
Time Frame: Day 0 (post dose) to Day 364
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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.
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Day 0 (post dose) to Day 364
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Median Serum Testosterone Levels
Time Frame: Day 0 (Baseline), Days 1,3,7,14, and 364
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Day 0 (Baseline), Days 1,3,7,14, and 364
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Median Prostate-specific Antigen Levels
Time Frame: Day 0 (Baseline), Days 3, 7, 14, and 364
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Day 0 (Baseline), Days 3, 7, 14, and 364
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Median Values of Di-Hydrotestosterone
Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
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Day 0 (Baseline), Days 1, 3, 7, 14, and 364
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Median Values for Serum Luteinizing Hormone
Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
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Day 0 (Baseline), Days 1, 3, 7, 14, and 364
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Median Values for Follicle Stimulation Hormone
Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364
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Day 0 (Baseline), Days 1, 3, 7, 14, and 364
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The Number of Patients With Abnormal Liver Function Tests
Time Frame: 364 days
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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.
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364 days
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The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight
Time Frame: Day 364
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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.
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Day 364
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Development Support, Ferring Pharmaceuticals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
June 1, 2005
Study Completion (Actual)
September 1, 2005
Study Registration Dates
First Submitted
January 7, 2009
First Submitted That Met QC Criteria
January 7, 2009
First Posted (Estimated)
January 8, 2009
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FE200486 CS12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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