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

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Hormones

Criteria

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