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临床试验/NCT01729676
NCT01729676已完成不适用

Impact of the Geographical FACTor on the Prostate Cancer Stage at Hormonal Therapy Initiation: FACT STUDY

Ferring Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2013年5月最近更新:
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
315
试验地点
1
主要终点
Estimated percentage of different prostate cancer stages (overall and by region)

研究概览

简要总结

French epidemiological data have shown a heterogeneous distribution of the risk of mortality from prostate cancer according to region. The main objective is to describe the distribution of prostate cancer stages when first line hormonal therapy is introduced (overall and by region).

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

  • Patients with histologically demonstrated prostatic adenocarcinoma.
  • Patients never previously treated with hormonal therapy for prostate cancer.
  • Patients eligible for hormonal therapy after initial consultation (alone or in combination with curative treatment).
  • Patients agreeing to the collection of personal health data for the purposes of the study.
  • Patients with locally advanced or metastatic prostatic cancer tumours or a biological recurrence after curative treatment.

排除标准

  • Patients participating in a clinical study involving prostate cancer at the time of inclusion in the investigation.
  • Patients having received or currently receiving hormonal treatment for prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor antagonists, antiandrogens, oestrogens, 5 alpha reductase inhibitors).

研究组 & 干预措施

Group A

Degarelix or gonadotrophin releasing hormone (GnRH) agonist for treatment of prostate cancer according to physicians current practice

干预措施: Degarelix or GnRH agonist (Drug)

结局指标

主要结局

Estimated percentage of different prostate cancer stages (overall and by region)

时间窗: During a single consultation when first-line prostate cancer hormone therapy is started

The stages of prostate cancer are classified as locally advanced, metastatic and biological recurrence.

次要结局

  • The characteristics of the patients with prostate cancer by region(During a single consultation when first-line prostate cancer hormone therapy is started)
  • The influence of regional factors on staging of prostate cancer(During a single consultation when first-line prostate cancer hormone therapy is started)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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