DRKS00005180招募中未知
Prospective phase II study of focal therapy (Hemiablation) of the prostate by high intensity focused ultrasound (HIFU) in patients with suitability for Active Surveillance (HEMI) - Hemi
niversitätsklinikum Regensburg0 个研究点目标入组 200 人开始时间: 2014年4月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 200
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
- 19 Years 至 one（—）
- 性别
- Male
入选标准
- •Patients aged > 18 years
- •Bioptic secured prostate cancer
- •Clinical stage T1c - T2a
- •PSA <= 10 ng/ml
- •Gleason Score <= 7a (3+4)
- •One-sided tumor attack
- •Proportion of infected tumor stamp in the total number of stamp of collected stamp <30% and the largest continuous tumor stove <5 mm
- •Height of the peripheral zone of the prostate to be treated in TRUS:
- •o = 30 mm when treated with Ablatherm Integrated Imaging
- •o = 40 mm when treatment with Focal One
- •No evidence of significant carcinoma of the opposite side in multiparametric MRI (defined as PI-RADS score 4 and 5)
- •Thickness of the rectal wall <6 mm in TRUS
- •Willingness of the participant to attend all follow-up visits (for 12 months)
排除标准
- •- Previous therapie of prostate cancer as radiation, hormonotherapy (including bilateral orchiectomy and plastic orchiectomy)
- •- Previous surgery of prostate and urethra within the last 6 month (TUR-prostate, urethrotomy, bladder neck incision)
- •- Taking of 5-alpha-reductase inhibitors (finasteride or dutasteride) within the last 6 month
- •- Stenosis of the rectum
- •- Acute urinary tract infection
- •- Acute bleeding coagulopathy
- •- Allergy of latex
- •- Participation of another clinical or pharmacological trial during the last 30 days
研究者
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