Open-Label, Randomised Parallel-Group Study
- Registration Number
- NCT00728533
- Lead Sponsor
- Ferring Pharmaceuticals
- 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 Ablation Therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
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 Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Degarelix * Starting dose of 240 mg (40 mg/mL) will be given on Day 0. * Maintenance doses of 480 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months. 1 Degarelix * Starting dose of 240 mg (40 mg/mL) will be given on Day 0. * Maintenance doses of 360 mg (60 mg/mL) will be given after 1, 4, 7, and 10 months
- Primary Outcome Measures
Name Time Method To demonstrate efficacy of degarelix in achieving and maintaining testosterone suppression at castrate levels (=0.5 ng/mL) during one year of treatment in prostate cancer patients. 3-month
- Secondary Outcome Measures
Name Time Method To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment. 3-month To evaluate pharmacokinetic response. 3-month To compare safety and tolerability profiles of different degarelix three-month dosing regimens. 3-month