Status:
WITHDRAWN
Open-Label, Randomised Parallel-Group Study
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
An Open-Label, Multi-Centre, Randomised Parallel-Group Study, Investigating Efficacy and Safety of Different Degarelix Three-Month Dosing Regimens in Patients with Prostate Cancer Requiring Androgen A...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients, aged 18 years or older, with a histologically proven prostate cancer of all stages in whom endocrine treatment is indicated.
- Screening testosterone level above the lower limit of normal range, globally defined as \> 2.2 ng/mL.
- Screening PSA level of =2 ng/mL. ECOG score of =2.
- Life expectancy of at least one year.
- CRITERIA FOR EVALUATION:
- Primary endpoint:
- Probability of testosterone at castrate level (=0.5 ng/mL) from Day 28 through Day 364.
- Secondary endpoints:
- Probability of testosterone at castrate level (=0.5 ng/mL) from Day 56 through Day 364.
- Serum levels of testosterone, LH, FSH, and PSA over time.
- Time to PSA failure - defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
- Plasma levels of degarelix over time.
- Frequency and severity of adverse events.
- Clinically significant changes in laboratory safety parameters.
- Clinically significant changes in physical examinations, ECGs, vital signs, and body weight.
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00728533
Last Update
March 18 2011
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