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

Ferring

Status and phase

Completed

Phase 4

Conditions

Prostate Cancer

Treatments

Drug: Degarelix

Study type

Interventional

Funder types

Industry

Identifiers

NCT02726009

000201

Details and patient eligibility

About

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.

Enrollment

230 patients

Sex

Male

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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