NCT04379362Unknown2 期
Magnetic Resonance Imaging-guided Focal Laser Ablation of Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Urine incontinence incontinence
研究概览
简要总结
Magnetic resonance imaging-guided focal laser ablation of prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 76 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Urine incontinence incontinence
时间窗: At inclusion, 3 months, 6 months, 12 months and 24 months follow up.
To evaluate a change in the functional outcome urine incontinence before and after FLA in patients with localized low to intermediate risk prostate cancer (Gleason 3+3, 3+4 or Gleason 4+3).
次要结局
- Sexual Health Inventory for Men- International Index of Erectile Function (SHIM-IIEF)(At inclusion, 3 months, 6 months, 12 months and 24 months follow up.)
- Complication rate(At inclusion , 3 months, 6 months, 12 months and 24 months follow up.)
- International Consultation on Incontinence Questionnaire (ICIQ)(At inclusion, 3 months, 6 months, 12 months and 24 months follow up.)
- Quality of life using a validated quality of life questionnaire (EORTC QLQ PR25(At inclusion , 3 months, 6 months, 12 months and 24 months follow up.)
- Local cancer control(At inclusion , 3 months, 6 months, 12 months and 24 months follow up.)
- International Prostate Symptom Score (IPSS)(At inclusion, 3 months, 6 months, 12 months and 24 months follow up.)
研究者
研究点 (2)
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