Evaluation of the Feasibility and Tolerance of Trans-rectal Focal Microwave Ablation of the Index Tumor in Patients With Low-risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Complete necrosis of the index tumor on prostate MRI
研究概览
简要总结
The purpose of this study is to determine if trans-rectal microwave ablation of the index tumor of patients with low-risk prostate cancer is sufficiently precise and safe, using MRI-transrectal ultrasound image registration.
详细描述
In men with low-risk prostate cancer, European and American guidelines recommend either active surveillance or whole-gland treatments, with significant induced morbidity and burden on quality of life. Focal treatments of the index tumor are currently under investigation to decrease morbidity while proposing active treatment.
The purpose of this study is to determine the feasibility, precision and safety of a novel ablation treatment using microwaves, delivered transrectally under real-time guidance with MRI-transrectal ultrasound image registration. The index tumor will be detected with prostate MRI and characterized with targeted biopsies using MRI-transrectal ultrasound image registration. It will then be ablated with microwaves using the same transrectal approach and guidance system (KOELIS).
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
- •Patients aged from 45 to 76 years old ;
- •Life expectancy above 10 years ;
- •Diagnosis of prostate cancer confirmed on prostate biopsies ;
- •Low risk of progression, defined with D'Amico criteria :
- •T1c or T2a stage
- •Maximum Gleason score of 3+4, including targeted biopsies corresponding to less than 50% grade 4 for the tumor
- •Prostate Specific Antigen <15 ng/mL
- •Detection of the index tumor with prostate MRI, characterized with targeted biopsies using MRI-transrectal ultrasound image registration ;
- •Patient accepting to be followed after the procedure using active surveillance protocol standards ;
- •Patient affiliated to national health care insurance ;
- •Free consent, informed and written, dated and signed by the patient and the investigator before enrollment.
排除标准
- •Medical past history of prostatic surgery ;
- •Medical past history of radiotherapy or pelvic trauma ;
- •Medical past history of acute or chronic prostatitis
- •severe BPH-related urinary tract symptoms defined as an IPSS >18 ;
- •Extra-capsular extension or seminal vesicle invasion on prostate MRI.
- •Tumor involvement > 3 mm on systematic biopsies outside the tumor volume detected on MRI.
- •Tumor largest axis > 20 mm on prostate MRI ;
- •Distance of less than 5 mm between the tumor and the rectum
- •Patient unable to understand the course of the study
- •History of allergy or non-tolerance to gadolinium salts used in MRI
- •Patient with a contraindication to performing an MRI
- •Person placed under safeguard of justice
结局指标
主要结局
Complete necrosis of the index tumor on prostate MRI
时间窗: 7 days
次要结局
- Margins of necrosis around the index tumor on prostate MRI(7 days)
- Erectile and Ejaculatory function using the International Index Erectile Function (IIEF) self questionnaire(6 months)
- Urinary symptoms using IPSS(6 months)
- Number of cancer on targeted biopsies within the treated volume(6 months)