Comparison of Prostate Cancer-related Quality of Life in Sexually Active Men With Favourable Intermediate-risk Localised Prostate Cancer Treated With Total Prostatectomy or Focal HIFU
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 102
- 试验地点
- 3
- 主要终点
- Quality of Life in relation to prostate cancer
研究概览
简要总结
The goal of this trial is to assess the impact of focal HIFU therapy on quality of life in patients with favourable intermediate-risk localised prostate cancer. The main question it aims to answer is:
What is the prostate cancer-related quality of life in patients with favourable intermediate-risk localised cancer treated by total prostatectomy or focal HIFU ?
Researchers will compare patients with favourable intermediate-risk localised cancer treated by total prostatectomy to patients with favourable intermediate-risk localised cancer treated by focal HIFU to see their quality of life.
Participants will answer EPIC-CP questionnaire 6 months, 12 months and 24 months after treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient, male, aged between ≥ 40 and ≤ 75 years
- •Patient with a life expectancy > 10 years at the time of inclusion.
- •Patient with a therapeutic strategy (prostatectomy or focal HIFU) defined during a PCR.
- •Patient with a diagnosis of localised prostate cancer at favourable intermediate risk
- •Patient able to tolerate general anaesthesia or type IV sedation
- •Patient with normal urinary continence status
- •Patient with satisfactory erectile function allowing penetration:
- •Patient with targeted biopsies and systematic biopsies
- •Patient affiliated to or benefiting from a social security scheme
- •French-speaking patients who do not object to the use of their data.
排除标准
- •Patients with a contraindication to MRI
- •Stage T3a or b on MRI
- •Patient on long-term anticoagulants and unable to stop them.
- •Patient already included in another study
- •Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
研究组 & 干预措施
Focal HIFU
Patient will undergo focal HIFU as a treatment for their cancer
干预措施: Focal HIFU (Procedure)
Total prostatectomy
Patient will undergo total prostatectomy as a treatment for their cancer
干预措施: Total prostatectomy (Procedure)
结局指标
主要结局
Quality of Life in relation to prostate cancer
时间窗: Month 6, month 12 and month 24
Quality of life in relation to prostate cancer will be assessed by the total score (ranging from 0 to 60) of the EPIC-CP (Expanded Prostate Cancer Index Composite for Clinical Practice) questionnaire. Higher score means a worse outcome.
次要结局
未报告次要终点