- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00738673
Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer
An Open-Label, Multi-Centre, Uncontrolled, Exploratory Trial Investigating Degarelix One-Month Dosing Regimen as Second-Line Hormonal Treatment After PSA-Failure in GnRH Agonist Treated Patients With Prostate Cancer
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Bautzen, Germany
- Urologische Praxis
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Berlin, Germany
- Urologische Praxis
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Berlin, Germany
- Urologische Klinik
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Borken, Germany
- Urologische Praxis
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Erkrath - Hochdal, Germany
- Urologische Praxis
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Hagenow, Germany, 19230
- Urologische Praxis
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Hamburg, Germany
- Martini Klinik
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Husum, Germany
- Urologische Praxis
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Kirchheim, Germany
- Urologische Praxis
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Köln, Germany
- Urologische Praxis
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Lauenburg/Elbe, Germany
- Urologische Praxis
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Leipzig, Germany
- Urologische Praxis
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Markkleeberg, Germany
- Urologische Praxis
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Planegg, Germany
- Urologische Klinik
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Rostock, Germany
- Wissenschaftskontor Nord
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient has given written informed consent before any trial-related activity is performed.
- Patient is 18 years or older.
- Histologically confirmed prostate cancer.
- Patient has received GnRH receptor agonist therapy for a duration of at least 12 months (the first dose of GnRH-antagonist is to be administered when the next dose of the GnRH-agonist would have been due).
- Patient has experienced rising PSA levels although receiving GnRH agonist therapy, defined as two consecutive rises of PSA at least two weeks apart in two 50% increases over the nadir, and at least one PSA value of >2.5 ng/mL within the last six months.
- Testosterone on castrate level (defined as ≤ 0.5 ng/mL) (cohort 1); Testosterone ≥0.2 ng/mL at inclusion (cohort 2)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Estimated life expectancy at least 12 months.
Exclusion Criteria:
- 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.
- Ongoing GnRH agonist therapy (last dose of previous GnRH agonist must have been received before Visit 1).
- Any pre-trial secondary hormonal manipulation (including antiandrogens) after PSA increase as described as above and before trial entry. Antiandrogens as part of complete androgen blockade must have been discontinued at least three months before first dose of trial medication.
- Previous or current treatment with chemotherapy (e.g. estramustine) for prostate cancer.
- Known hypersensitivity towards any component of the investigational medical product.
- History of severe uncontrolled asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
- Known or suspected clinically significant liver and/or biliary disease.
- Any clinically significant laboratory abnormalities, disorders, or other condition, including alcohol or drug abuse, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
- Patient has a clinically significant disorder (other than prostate cancer) including, but not limited to, renal, hematological, 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.
- Patient has a mental incapacity or language barriers precluding adequate understanding or co-operation.
- Patient has received an investigational drug within the last 28 days preceding screening visit. Or longer if considered to possibly influencing the outcome of the current trial.
- Previous participation in any degarelix trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Degarelix
Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections. |
Starting dose of 240 mg (40 mg/mL).
Maintenance doses of 80 mg (20 mg/mL).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants' Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline
Time Frame: Day 0 (baseline), 3 months
|
Response to treatment was defined as:
|
Day 0 (baseline), 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants' Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline
Time Frame: Day 0 (baseline), 1 month
|
Response to treatment was defined as:
Per protocol, the one month timeframe was only analyzed for cohort 2. |
Day 0 (baseline), 1 month
|
Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline
Time Frame: Day 0 (baseline), 2 months
|
Response to treatment was defined as:
Per protocol, the two month timeframe was only analyzed for cohort 2. |
Day 0 (baseline), 2 months
|
Participants at Testosterone Castrate Level Throughout the Study
Time Frame: up to month 12
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Participants who had no post-baseline serum testosterone level above castrate level which was <=0.5 ng/mL.
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up to month 12
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Change From Baseline in Serum Levels of Testosterone at the Last Visit
Time Frame: Day 0 (baseline), up to month 12 (last visit)
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Day 0 (baseline), up to month 12 (last visit)
|
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Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit
Time Frame: Day 0 (baseline), up to month 12 (last visit)
|
Day 0 (baseline), up to month 12 (last visit)
|
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Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit
Time Frame: Day 0 (baseline), up to month 12 (last visit)
|
LH is measured in IU/L
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Day 0 (baseline), up to month 12 (last visit)
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Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit
Time Frame: Day 0 (baseline), up to month 12 (last visit)
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Day 0 (baseline), up to month 12 (last visit)
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Participants at Testosterone Level <=0.2 ng/mL Throughout the Study
Time Frame: up to month 12
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Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.2 ng/mL.
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up to month 12
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Participants at Testosterone Level <=0.32 ng/mL Throughout the Study
Time Frame: up to month 12
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Participants in Cohort 2 who had no post-baseline serum testosterone level above 0.32 ng/mL
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up to month 12
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Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study
Time Frame: up to month 12
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Counts of participants who had PSA progression during the study.
PSA progression was defined as PSA >+10% of baseline value.
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up to month 12
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Kaplan-Meier Estimate for Overall Survival
Time Frame: up to month 12
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The overall survival time was defined as number of days from first treatment dose to date of death.
If a patient did not die then the patient's data were censored at the date of last visit.
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up to month 12
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FE200486 CS27
- 2008-000585-22 (EudraCT Number)
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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