Primary Outcome Measures:
- Changes in clinical safety parameters (adverse events including death from any causse, physical examination, vtal signs, ECGs, and body weight)
- Clinical significant changes in laboratory safety parameters (clinical chemistry, haematology, and urinalysis)
Secondary Outcome Measures:
- Proportion of patients with testosterone level maintained at ≤0.5 ng/mL from start of FE 200486 cs21a and onwards.
- Proportion of patients treated with degarelix with testosterone level maintained at ≤0.5 ng/mL from Day 28 in FE 200486 CS21 and onwards.
- Proportion of patients switching from LUPRON DEPOT 7.5 mg to Degarelix with testosterone level maintained below 0.5 ng/mL from Day 28 in Fe 200486 CS21A and onwards.
- Time to testosterone level above 0.5 ng/mL.
- Serum levels of testosterone and PSA over time.
- Time to PSA progression-defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either FE 200486 CS21 or FE 200486 CS21A)
- Serum levels of testosterone, PSA, LH, and FSH from the time of switch from LUPRON DEPOT to degarelix.
An extension study to evaluate long-term safety, tolerability, and efficacy of one-month dosing regimen of degarelix for treatment of prostate cancer.
Primary Objective:
To evaluate safety and tolerability during long-term treatment with degarelix one-month dosing regimen in prostate cancer patients.
Secondary Objectives:
To evaluate testosterone response during long-term treatment with degarelix one-month dosing regimen.
To evaluate PSA response during long-term treatment with degarelix one-month dosing regimen.
To evaluate testosterone, PSA, LH, and FSH responses from the time of switch from LUPRON DEPOT® to degarelix.
Purpose
