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临床试验/NCT01574846
NCT01574846已完成不适用

Prospective, Multicentre, Non-interventional (Observational) Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer.

Orion Corporation, Orion Pharma1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
142
试验地点
1
主要终点
Treatment duration follow-up for each patient.

研究概览

简要总结

The aim of this non-interventional (observational) study is to document, in collaboration with established urologists in Scandinavia, experience gained from routine use of Vantas® for the treatment of patients with advanced prostate cancer. In this observational study particular attention will be directed to treatment duration, quality of life and patient and physician acceptance of the medicinal product for long-term therapy. Patient-based measurement parameters such as quality of life and degree of satisfaction will allow registration of information that extends beyond the clinical parameters. The knowledge gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical outcome will also be documented by measuring serum testosterone and prostate specific antigen (PSA) levels.

研究设计

研究类型
Observational
观察模型
Case Only
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 patients for whom hormone treatment for advanced prostate cancer is indicated
  • Age > 18 years.
  • Documented elevated PSA levels.

排除标准

  • Contraindications for Vantas® (in accordance with Summary of Product Characteristics (SmPC))

结局指标

主要结局

Treatment duration follow-up for each patient.

时间窗: 1 year

次要结局

  • Quality of Life measurements(1 year)
  • Blood samples(1 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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