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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
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.
Time frame: 3-month
To evaluate testosterone, PSA, LH, and FSH responses during one year of treatment.
Time frame: 3-month
To evaluate pharmacokinetic response.
Time frame: 3-month
To compare safety and tolerability profiles of different degarelix three-month dosing regimens.
Time frame: 3-month
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