A Study of Degarelix in Taiwanese Patients With Prostate Cancer

An Open-label, Multi-centre Registration Trial, Investigating Efficacy and Safety of Degarelix One-month Dosing Regimen in Taiwanese Patients With Prostate Cancer Requiring Androgen Ablation Therapy

A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.

Inclusion Criteria:

• 20 years or older
• Has a histological confirmed prostate cancer
• Has a screening serum testosterone above 1.5 ng/mL
• Has a Eastern Cooperative Oncology Group (ECOG) score of ≤ 2
• Has a screening PSA value of ≥2 ng/mL
• Has a life expectancy of at least 168 days

Exclusion Criteria:

• Current or previous hormone therapy
• Is currently treated with 5-α-reductase inhibitor
• Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema
• Is considered to be a candidate for curative therapy, i.e radical prostatectomy or radiotherapy
• Has had cancer within the last five years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin.
• Has a clinically significant disorder (other than prostate cancer) or any other condition , including alcohol or drug abuse, which may interfere with trial participation or which may affect the conclusion of the trial as judged by the investigator
• 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