Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

An Open-label, Multi-Centre Trial Investigating Pharmacokinetics of Degarelix After a Starting Dose of 240 mg (40 mg/mL) Followed by Six Maintenance Doses of 80 mg (20 mg/mL) in Chinese Patients With Prostate Cancer Requiring Androgen Deprivation Therapy

The purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.

Inclusion Criteria:

• Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated
• Has a Prostate-specific Antigen (PSA) level ≥2.0 ng/mL at Screening
• Has a screening serum testosterone level >150 ng/dL
• Has an Eastern Cooperative Oncology Group (ECOG) score of ≤2

Exclusion Criteria:

• Has had previous or is currently under hormonal management of prostate cancer. However, hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit
• Is currently treated with a 5-alpha reductase inhibitor
• Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
• Is in need of neoadjuvant hormonal therapy
• Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy