A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON

Study Overview
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Brief Summary
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This study is a large observational study, set-up to observe how long-term treatment with FIRMAGON (hormone regulator) compare to other treatments in regards to cardiovascular events, changes in bone density, changes in blood sugar levels or liver enzyme levels in subjects with prostate cancer. Subjects will be treated according to their routine clinical care and not dictated by the study. As the study is observational in nature, the study will collect data relating to the events specified above. Subjects that agree to this study will be followed-up for 5 years. Subject data will be collected every 3 months for the first 2 years and every 6 months for the last 3 years.

Official Title
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A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with prostate cancer and indicated for androgen deprivation therapy (ADT) Decision made to prescribe ADT prior to enrolment Willing and able to provide written informed consent Exclusion Criteria: Participation in an interventional clinical study in which any treatment or follow-up is mandated Treatment with a GnRH receptor antagonist other than FIRMAGON Had previous or is currently under hormonal management of prostate cancer, except for subjects who have undergone therapy with curative intention where neoadjuvant/adjuvant therapy allowed for maximum 6 months. Treatment should be terminated at least 6 months prior to baseline.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| FIRMAGON<br> | |
| GnRH Agonist<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events | The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE). | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | 
| Incidence Rate of AESI: Decreased Bone Density | IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE. | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | 
| Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM) | IR of new onset or exacerbation of glucose intolerance or T2DM were presented. The IR expressed as number of events per 100 PYE. Glucose intolerance events were defined as events of levels of fasting glucose of 6.1 to 6.9 mmol/L | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | 
| Change in Hepatic Enzymes | Change from baseline in hepatic enzyme levels (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and alkaline phosphatase [ALP]) are presented. | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | 
| Change in Hepatic Enzymes | Change from baseline in hepatic enzyme level (bilirubin) is presented. | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | 
| Change in Serum Glucose | Change from baseline in serum glucose are presented. | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Classification of New Adverse Drug Reactions (ADRs) | An ADR was defined as an AE assessed by investigator as possibly/probably related to the investigational product. Any new potentially unrecognized ADRs were presented. | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | 
| Long Term Evaluation of Clinical Evolution of Prostate Cancer | Change in prostate specific antigen (PSA) is presented. | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | 
| Changes in Testosterone Levels | Change from baseline in testosterone levels are presented. | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) | 
| All-cause of Mortality | A summary of IRs of all-cause mortality is presented. | From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study) |