Intérêt de la radiothérapie Adaptative en stéréotaxie Prostatique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of patients requiring dosimetric recalculation due to anatomical variations
研究概览
简要总结
This study evaluates whether adaptive stereotactic body radiotherapy (SBRT) provides dosimetric advantages compared to non-adaptive SBRT in localized prostate cancer. Five low-dose CT scans are performed before each SBRT session to assess anatomical variations (bladder filling, rectal volume) and determine if a dosimetric recalculation would have been required. The study also evaluates cumulative dose to organs at risk, patient-reported quality of life over 24 months, and overall and recurrence-free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male aged ≥60 years
- •Localized prostate cancer of low or intermediate risk (T1-T2)
- •Gleason score 6-7
- •PSA <15 ng/mL
- •No evidence of metastatic disease
- •Radiotherapy indicated for prostate cancer
- •Affiliated with or benefiting from a French social security system
- •French-speaking patient
- •Patient appropriately informed and having signed a written informed consent form
排除标准
- •Unable to read, write, or understand French
- •Vulnerable patient as defined by Article L1121-6 of the French Public Health Code
- •Adult under guardianship, curatorship, or legal protection ("sauvegarde de justice")
- •Patient unable to personally provide informed consent according to Article L1121-8 of the French Public Health Code
- •Patient already included in another interventional study that could interfere with study outcomes
- •History of urological (prostate) or digestive surgery that could influence study outcomes
- •Refusal to sign the written informed consent form
结局指标
主要结局
Proportion of patients requiring dosimetric recalculation due to anatomical variations
时间窗: At each of the 5 SBRT sessions (10 days max) Based on scanners low-dose comparison.
Percentage of patients for whom at least one stereotactic body radiotherapy (SBRT) fraction would have required a dosimetric recalculation due to anatomical variations (bladder filling and/or rectal emptying), based on comparison between the initial treatment plan and pre-treatment low-dose CT scans acquired before each SBRT fraction (5). This outcome reflects the potential benefit of an adaptive radiotherapy approach compared to a non-adaptive strategy.
次要结局
- Cumulative delivered dose to Organs at Risk (OARs)(From baseline CT + all 5 fraction low-dose CT scans. (up to 10 days))
- Change from baseline in global quality of life (EORTC QLQ-C30)(Time Frame: Baseline (pre-radiotherapy) 1 month 3 months 6 months 12 months 18 months 24 months post-radiotherapy)
- Survival outcomes(1, 3, 6, 12, 18, 24 months post-radiotherapy)
- Recurrence-Free Survival (RFS)(1, 3, 6, 12, 18, 24 months post-radiotherapy)
- Change from baseline in prostate cancer-specific quality of life (EORTC QLQ-PR25)(Baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy)
- Change from baseline in urinary symptoms (IPSS)(Baseline, 1, 3, 6, 12, 18, and 24 months post-radiotherapy)