NCT03996005已完成不适用
Evaluation of an Alternative Treatment of Localized Prostate Cancer by Guided MRI Transurtral Ultrasound With 1-year Control of the Absence of Cancer
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年9月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up.
研究概览
简要总结
Primary purpose :
Evaluation of the efficiency and safety of an alternative global prostate treatment in localized prostate cancer.
Primary Objective:
Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up.
Secondary Objectives:
- Biochemical response
- Presence of any CSC on biopsy at 1- and 2-year follow-up
- Radical treatment free survival
- Adverse events, clinical tolerance
- Urinary continence
- Erectile function
- Quality of life
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
- 80 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient ≥ 50 years old
- •Histologically confirmed adenocarcinoma of the prostate
- •Gleason ≤ 7 (3 + 4) ; Grade group ≤ 2 according to Epstein
- •Clinically <T3, N0, M0
- •PSA < 15 ng/mL
- •Prostate volume <100g
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Life expectancy higher than 12 months in the judgement of the investigator
- •Radiological TNM (prostate MRI) T ≤ 2 (absence of extra-capsular extension, absence of seminal vesicle invasion), N = 0, M = 0
- •First line of treatment or relapse after initial radiotherapy
- •Willing to give signed, informed consent freely
- •Able to adhere to the follow-up schedule and other protocol requirements.
排除标准
- •Contraindication to MRI
- •Contraindication to general anesthesia
- •Presence or history of any other malignancy except for non-melanoma skin cancer adequately treated at least 2 years before study entry
- •Unreversible haemostasis disorder
研究组 & 干预措施
MRI Guided Transurethral Ultrasound
Experimental
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
干预措施: Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue (Procedure)
结局指标
主要结局
Absence of Clinically Significant Cancer (CSC) on Control Biopsy at 1-year Follow-up.
时间窗: 1 year
Clinically significant cancer (CSC) defined by at least one of the following criteria: * Gleason score ≥ 7 * cancer core length \> 3 mm regardless of Gleason score * \> 2 positive cores.
次要结局
未报告次要终点
研究者
研究点 (1)
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