NCT03407963已完成不适用
Feasibility of Prostatic Arterial Embolization in Low-risk Patients With Unilateral Prostate Cancer Under Active Surveillance: Monocentric Pilot Study
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年6月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Complications arising from embolization
研究概览
简要总结
The authors hypothesize that, in patients with low volume tumors identified according to anatomo-pathological criteria and imaging, and under active surveillance focal, therapy by unilateral embolization of prostatic arteries will provide local control of the tumor via selective ischemia
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The patient must have given their free and informed consent and signed the consent form
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient is between 18 and 80 years old
- •Patient has unilateral prostate cancer, stage TNM<T2b with an MRI PiRAds target ≥ 3 in concordance with biopsy result
- •Biopsy gives a Gleason score ≤ 6 with more than 3 positive biopsies per lob and at least 50% the length of the positive biopsy; patients over 70 years old with a Gleason score = 7 (3+4) can be included
- •Patient has a life expectancy of over 10 years
- •PSA <10ng/ml; patients with a large prostatic volume and PSA ≥ 10ng/ml can be included according to doctor discretion.
排除标准
- •The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient unresponsive to active surveillance
- •Patient refusing active surveillance
- •Patients in a state unfit to express personal consent cannot be solicited (eg patients undergoing psychiatric treatment with mental difficulties rendering consent impossible)
- •Contraindication for MRI (pacemaker incompatible with MRI, claustrophobia, metal device, prosthetic hip replacement)
- •Patient with hemostasis disorder.
- •Cancer in both prostate lobes
结局指标
主要结局
Complications arising from embolization
时间窗: Month 6
Presence/absence of complications beyond those expected linked to embolization (persistent urinary infection, dysuria, rectorrhagia, hematuria, hemospermia, acute urinary retention and pelvic perineal pain)
Presence of cancerous cells
时间窗: Month 6
Positive/negative according to biopsy of treated lobe
次要结局
- Global survival(Month 6)
- Use of other mode of treatment(Month 6)
- Necrosis of treated lobe(Month 6)
- Change in size of target(Month 6)
- Prostate specific antigen level(Month 6)
- Occurrence of undesirable events linked to embolization or the femoral access classified according to Clavien-Dindo classification(Month 6)
- Urinary symptoms(Month 6)
- Incontinence(Month 6)
- Erectile dysfunction(Month 6)
- Health-related quality of life(Month 6)
研究者
研究点 (2)
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