DRKS00008770进行中（未招募）未知
Multicentric, prospective, randomized study to evaluate the effect of standard drug therapy with or without radical prostatectomy (RP) in patients with limited bone metastatic prostate cancer - g-RAMPP
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 129
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 74 Years（—）
- 性别
- Male
入选标准
- •1. Patients with newly diagnosed prostate cancer which has been confirmed by histological examination (within the last 6 months prior to randomization)
- •2. At least one and at most 5 bone metastases in imaging tests (bone scintigraphy, CT, MRT or PET) at diagnosis with no evidence of visceral metastasis. Patients with evidence of lymph node metastasis (N1) are allowed
- •3. PSA = 200 ng/ml at diagnosis (without systemic therapy)
- •4. Asymptomatic or mild symptomatic disease
- •5. Locally resectable tumour stage
- •6. ECOG Performance Status 0-1
- •7. Submission of the patient’s written declaration of informed consent following explanation
- •8. Age = 18 - = 75 years
- •9. Full legal capacity and compliance of the patient
排除标准
- •1. Contraindications to radical prostatectomy (locally non-resectable disease, increased anaes-thesia risk with corresponding comorbidity)
- •2. Evidence of more than 5 bone metastases
- •3. Pain management with opioid analgesics
- •4. Evidence of visceral metastases or brain metastases
- •5. Neuroendocrine and/or small cell differentiation in the histology of the biopsy
- •6. Charlson Comorbidity Index > 2
- •7. ECOG Performance Status >1
- •8. Myocardial infarction or stroke within the last 6 months
- •9. Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or haematopoietic (e.g. severe bone
- •marrow aplasia) disease
- •10. Severe psychiatric disorders in persons housed by a judicial or administrative arrangement in an institution
- •11. Simultaneous participation in another clinical study with interventional character of the meta-static prostate cancer
研究者
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