NCT02200809已完成不适用
MR-guided Focal Laser Ablation of the Prostate
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Disease free survival
研究概览
简要总结
Purpose of the investigators study is to determine the short and medium term histological cancer control of focal therapy using MR-guided focal laser ablation therapy in the treatment of localised 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed and biopsy proven prostate cancer
- •Intermediate risk patients (PSA <= 20 ng/mL, Gleason ≤ 7, T2b)
- •No previous treatment for prostate cancer
- •Cancer lesion located at least 1 cm away from the neurovascular bundle according to Multimodality MR images
- •Signed informed consent by patient
- •Age 18 years or older
- •Signed screening form (to determine exclusion for metal device/foreign bodies/claustrophobia)
排除标准
- •Impossibility to obtain a valid informed consent
- •Patients unable to undergo MR imaging, including those with contra-indications
- •Contra-indications to MR guided focal laser therapy (colitis ulcerosa, rectal pathology or abdomino perineal resection)
- •Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MR imaging
- •Patients with evidence for nodal or metastatic disease
- •Patients with an estimated Glomerular Filtration Ratio (eGFR) < 40 mL/min/1.73 m2
结局指标
主要结局
Disease free survival
时间窗: 36 months.
The short and medium term histological cancer control defined as the percentage of patients with disease free survival according to the pathological MR-guided biopsy results after 36 months.
次要结局
未报告次要终点
研究者
研究点 (4)
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