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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Degarelix


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Degarelix<br> | Drug: Degarelix<br> <br> * Other names: Firmagon®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events |  | Up to Day 364 | 
| Severity of adverse events |  | Up to Day 364 | 
| Clinically significant changes in laboratory values (hematology and clinical biochemistry) |  | From baseline to Day 364 | 
| Clinically significant changes in vital signs |  | From baseline to Day 364 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative probability of no Prostate Specific Antigen (PSA) failure | PSA failure defined as an increase in serum PSA of 50%, and at least 5 ng/mL, compared to nadir, measured on two consecutive occasions at least 2 weeks apart | Up to Day 364 | 
| Cumulative probability of Progression Free Survival (PFS) | PFS defined as PSA failure, death from any cause, or introduction of additional therapy related to prostate cancer, whichever is first | Up to Day 364 | 
| Change in International Prostate Symptom Score (IPSS) |  | From baseline to Day 364 | 
| Change in physician's satisfaction score |  | From baseline to Day 364 |