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
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 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