A Prospective Observational Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON (Degarelix) or a GnRH Agonist
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,493
- 试验地点
- 158
- 主要终点
- Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Incidence Rate of Adverse Events of Special Interest (AESI): Cardiovascular Events
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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
次要结局
- 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))
- 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))
- 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))
- 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))