Open-Label, Randomised Parallel-Group Study

The Rationale of the Study is to Demonstrate That Degarelix Given at Three-month Dosing Intervals Will Produce and Maintain Androgen Deprivation in Prostate Cancer Patients Through Immediate and Prolonged Testosterone Suppression, and to Provide Confirmatory Evidence of the Safety of Degarelix.

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.

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.