A Trial to Evaluate Safety of Firmagon® (Degarelix) in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer

An Open-label, Single-Arm, Multicenter, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed With Advanced Hormone-dependent Prostate Cancer

The purpose of this open-label, single-arm, multicenter, post-marketing trial is to evaluate long-term safety of Firmagon® in approximately 230 Indian patients diagnosed with advanced hormone-dependent prostate cancer requiring androgen deprivation therapy.

Inclusion Criteria:

• Has given written informed consent before any study-related activity is performed
• Advanced hormone-dependent prostate cancer for which androgen deprivation therapy is indicated, and independently from this trial, Firmagon® is intended to be used for treatment
• Age greater than or equal to 18 years and less than 80 years
• Advanced hormone-dependent prostate cancer without any other clinically significant disorder
• Easten Cooperative Oncology Group score ≤ 2
• PSA ≥ 2 ng/mL at screening
• Life expectancy of at least 12 months as per the investigator's judgement

Exclusion Criteria:

• Previous or concurrent hormonal management of prostate cancer
• Contraindication for prescription of Firmagon®
• Concurrent treatment with a 5-α-reductase inhibitor
• Considered as a candidate for curative therapy
• History of severe untreated asthma, anaphylactic reactions or severe urticaria and/or angioedema
• QTc interval over 450 msec or risk factors for torsades de pointes or on Class IA and Class III anti arrhythmic medications
• Cancer within the last 5 years except prostate cancer and surgically removed basal or squamous cell carcinoma of the skin
• Known or suspected hepatic, symptomatic biliary disease (this includes moderate to severe chronic hepatic impairment)
• Patients with clinically significant laboratory abnormalities / disorders other than prostate cancer
• Patient with Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) infections