DRKS00010911已完成1 期
ocal HDR brachytherapy in case of localized prostate cancer - ProFocA
niversitätsklinik für Radiologie und Nuklearmedizin0 个研究点目标入组 37 人开始时间: 2016年8月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years(—)
- 性别
- Male
入选标准
- •Patients between 18 and 80 years, with a localized tumor of the prostate under low-risk or intermediate risk early to D'Amico, the standard procedures, such as percutaneous radiotherapy, radical prostatectomy or active surveillance refuse.
- •In preoperatively performed multiparametric MRI (mpMRT) at least one suspicious lesion with a PI-RADS score must be described by 4/5.
- •Age 18 aged 80 or a life expectancy of at least 10 years
- •MR biopsy or prostate fusionsbioptisch secured
- •In accordance distinctly visible index lesions with PI-RADS score 4/5
- •consent of focal treatment by using brachytherapy
- •refusal of also introduced standard treatments
排除标准
- •several suspect lesion in mpMRT with a PI-RADS score of 4/5. Furthermore, symptoms that preoperatively additional treatments of the prostate makes necessary (z. B. TURP) equipment and other obstacles which do not allow to carry out the therapy.
- •Missing capacity to consent
- •evidence of lymph node or metastasis in the CT or MRI
- •no suspect MR lesion (PIRADS 4/5)
- •several suspect MR lesions (PIRADS 4/5)
- •ongoing antihormonal therapy
研究者
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