NCT01710098已完成不适用
Effectiveness and Safety as Well as Adherence of the "S3 Guidelines for the Treatment of Prostate Cancer" in the Treatment of Patients of Patients With Firmagon®
United Clinic Management GmbH1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年6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
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PSA-/Testosterone Level
研究概览
简要总结
How are testosterone levels of patients with prostate cancer under treatment with Firmagon® changing.
Former studies showed a quick fall of testosterone levels after start of therapy with Firmagon® and a quick recovery when therapy is stopped. The investigators want to prove this in a normal outpatient urologist setting. Furthermore data is collected to prove the adherence to the German S3-Guideline for the treatment of prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •advanced hormone-dependent prostate cancer with no other previous hormone therapy for whom - irrespectively of this NIS -the use of Firmagon® is intended
排除标准
- •contraindication for Degarelix
研究组 & 干预措施
Degarelix
adult male patients with advanced hormone dependent prostate cancer who receive 240 mg as a start dose and then monthly 80mg Firmagon® for one year
干预措施: Degarelix (Drug)
结局指标
主要结局
PSA-/Testosterone Level
时间窗: 12 months
次要结局
- Anxiety(12 Months)
- S3 Guideline(12 months)
研究者
Karin Buchsteiner
Head of Study Group
United Clinic Management GmbH
研究点 (1)
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