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

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events	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)	The incidence rate (IR) expressed as number of events per 100 patient-years of exposure (PYE).
Change in Hepatic Enzymes	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 from baseline in hepatic enzyme level (bilirubin) is presented.
Incidence Rate of AESI: Decreased Bone Density	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)	IR of osteoporosis or osteopenia and bone fracture events are presented. The IR is expressed as number of events per 100 PYE.
Change in Serum Glucose	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 from baseline in serum glucose are presented.
Incidence Rate of AESI: Glucose Intolerance or Type 2 Diabetes Mellitus (T2DM)	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)	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

Secondary Outcome Measures

Name	Time	Method
Changes in Testosterone Levels	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 from baseline in testosterone levels are presented.
All-cause of Mortality	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)	A summary of IRs of all-cause mortality is presented.
Long Term Evaluation of Clinical Evolution of Prostate Cancer	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 prostate specific antigen (PSA) is presented.
Number and Classification of New Adverse Drug Reactions (ADRs)	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)	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.

Locations (158): Onze-Lieve-Vrouwziekenhuis
🇧🇪
Aalst, Belgium
Ziekenhuisnetwerk Antwerpen - AZ Stuivenberg
🇧🇪
Antwerpen, Belgium
AZ Sint-Jan AV
🇧🇪
Brugge, Belgium
Hôpitaux IRIS Sud
🇧🇪
Bruxelles, Belgium
Université Catholique de Louvain
🇧🇪
Bruxelles, Belgium
Hôpital Erasme
🇧🇪
Bruxelle, Belgium
AZ Sint-Blasius
🇧🇪
Dendermonde, Belgium
AZ Jan Palfijn
🇧🇪
Gent, Belgium
AZ Maria Middelares
🇧🇪
Gent, Belgium
AZ Sint-Lucas
🇧🇪
Gent, Belgium
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Onze-Lieve-Vrouwziekenhuis
🇧🇪Aalst, Belgium