Comparison of Prostate Cancer Detection Rates Obtained With Multiparametric MRI Targeted Transrectal Ultrasound Biopsies and Systematic Transrectal Ultrasound Biopsies.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 12
- 主要终点
- Carcinomatous invasion on biopsies samples
研究概览
简要总结
The purpose of the study is to show that 3 targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system, will get no lower rate of cancer detection than those obtained by 12 systematic transrectal ultrasound-guided biopsies of the prostate.
详细描述
The act of current practice evaluated by this research is the act of prostate biopsies : the patient will have to undergo 12 systematized transrectal echography guided biopsies of the prostate and 3 additional biopsies targeted on the suspicious lesion detected with MRI, which are both done in current practice.
- A first operator is not informed of the location of the target. He will perform a series of 12 systematic transrectal ultrasound-guided biopsies of the prostate.
- Immediately after the second operator will perform 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system
Act added by the research: Using a fusion of MRI - ultrasound images software system (Koelis ®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patient from 45 to 75 years old;
- •Serum level of PSA > 4,0 ng / mL;
- •Multiparametric prostate IRM, performed before inclusion and which confirm the diagnosis of suspected target;
- •No opposition of the patient notified in the medical record
- •patient member in a national insurance scheme.
排除标准
- •Previous prostate biopsy;
- •suspicious digital rectal examination;
- •serum PSA > 20,0 ng / mL;
- •treatment with 5 alpha reductase inhibitor during the last 3 months;
- •untreated urinary infection
研究组 & 干预措施
Targeted biopsies guided by a fusion of MRI and ultrasound
After the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system
干预措施: systematic biopsies (Procedure)
Targeted biopsies guided by a fusion of MRI and ultrasound
After the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system
干预措施: Targeted biopsies guided by a fusion of MRI and ultrasound- images (Procedure)
Systematic biopsies
The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
干预措施: systematic biopsies (Procedure)
Systematic biopsies
The patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
干预措施: Targeted biopsies guided by a fusion of MRI and ultrasound- images (Procedure)
结局指标
主要结局
Carcinomatous invasion on biopsies samples
时间窗: Day 15
The presence of carcinomatous invasion on biopsies samples
次要结局
- Respective duration of each biopsy protocol(Day 0)
- Biopsy Gleason score of the detected cancer(Day 15)
- Tissue length of biopsy invaded by the detected cancer(Day 15)