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临床试验/NCT03193645
NCT03193645已完成不适用

Observational Prospective Study Describing the Global Patient Care and Follow-up of Prostate Cancer Patients Treated With Degarelix (DUO)

Ferring Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年6月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Occurrence of cardiovascular comorbidity

研究概览

简要总结

The DUO study's main objective is to evaluate, in the real life, the prevalence of cardiovascular risk in patients with prostate cancer that hormone treatment of androgen suppression by Degarelix was introduced.

This study will also assess, at the initiation of therapy, the prevalence of osteoporosis, metabolic comorbidities, depression, sexual and geriatric patients suffering from prostate cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male aged 18 years or older
  • Diagnosed with prostate cancer
  • Patient having received an antagonist of GnRH Degarelix prescription.
  • Agreeing to and capable of completing in French during the visits all questionnaires on the impact of their illness and treatment.
  • Patients having received oral and written study information, agreeing to the use of his anonymized data, and having signed a written Informed Consent Form.

排除标准

  • Patient included in an interventional study assessing treatment for prostate cancer.
  • Patient presenting hypersensitivity to Degarelix or one of its excipients.
  • Patient treated by other hormonotherapy.

研究组 & 干预措施

Degarelix

干预措施: Degarelix (Drug)

结局指标

主要结局

Occurrence of cardiovascular comorbidity

时间窗: At inclusion

Measured by a history of at least one cardiovascular illness (according to ICD-10) and/or at least three cardiovascular risk factors (as defined by Cancer Committee of the French Urology Association)

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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