DRKS00004981已完成3 期
Effectiveness of Zometa® treatment for the prevention of bone metastases in high risk prostate cancer patients - ZEUS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,433
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 99 Years（—）
- 性别
- Male
入选标准
- •1. Eastern Cooperative Oncology Group (ECOG) = 0 (Karnofsky-Index 90)
- •2. M0 prostate cancer patients who previously received local treatment (e.g. surgery, radiotherapy) or no local treatment. The time frame between local treatment and starting of the study must not be longer than 6 months.
- •3. At least one of the following conditions must be present:
- •a) Gleason Score 8-10
- •c) PSA =/< 20 at first diagnosis
- •4. Life expectancy of > 6 months
- •5. Signed informed consent prior to initiation of any study procedure.
排除标准
- •1. Patients with known organ metastases or bone metastases
研究者
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Effectiveness of Zometa® treatment for the prevention of bone metastases in high risk prostate cancer patients: a randomised, open-label, multicentre study of the European Association of Urology (EAU) in Cooperation with the Scandinavian Prostate Cancer Group (SPCG) and the Arbeitsgemeinschaft Urologische Onkologie (AUO)Malignant neoplasm of the prostateCancerProstate cancerISRCTN66626762European Association of Urology (The Netherlands)1,300
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