Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

Exclusion Criteria

• •Has had previous or is currently under hormonal management of prostate cancer. However, prostatectomy or radiotherapy with curative intention, neoadjuvant/adjuvant hormonal therapy are accepted for a maximum duration of 6 months, at least 6 months prior to Screening Visit
• •Is currently treated with a 5-α-reductase inhibitor
• •Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy
• •Has a history of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
• •Has hypersensitivity towards any component of the investigational medicinal product
• •A marked baseline prolongation of QT/QTcF interval
• •A history of additional risk factors for Torsade de Pointes ventricular arrhythmias
• •Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
• •Has a known or suspect hepatic, symptomatic biliary disease
• •Has elevated serum ALT level more than the upper limit of normal or serum total bilirubin level above the upper level of normal range at the Screening Visit and confirmed with a second measurement within 21 days
• •Has other clinically significant laboratory abnormalities
• •Has a clinically significant disorder (other than prostate cancer) or any other condition, including alcohol or drug abuse
• •Has a mental incapacity or language barriers precluding adequate understanding or co- operation
• •Has received an investigational drug within the last 28 days preceding Screening Visit or longer if considered to possibly influence the outcome of the current trial
• •Has previously participated in any degarelix trial