ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- urinary toxicity analysis (IPSS)
研究概览
简要总结
Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 & 10 years.
详细描述
Phase 1 : consists in a feasibility study (First 28 patients).
Phase 2 : monocentric prospective comparative cohort study.
Recruitment :
- "Centre intégré de cancérologie du CHU de Québec-Université Laval."
- Recruitment period: December 2015 to June 2023
Brachytherapy :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Biopsy proven Prostate adenocarcinoma
- •Stage T1c, T2 (Annex 2)
- •Stage Nx or N0
- •Stage Mx or M0
- •PSA < 20ng/ml
- •Gleason Score 6 or 7
- •Having the ability to sing a written consent
排除标准
- •Age < 18ans
- •Clinical Stage T3 or T4
- •PSA > 20
- •Gleason Score 8 to 10
- •IPSS Score > 20 alpha-blocking medication.
- •Prior pelvic radiotherapy.
- •History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)
- •Past history of Inflammatory Bowell Disease
- •Bilateral hip prosthesis
研究组 & 干预措施
ultra hypo fractionation radiation therapy
comparative PRO's of 25 Gy in 5 daily fractions (Ultra hypo fractionation) administered to prostate and 1st centimeter of proximal seminal vesicle, starting mid week and ending mid following week.
干预措施: grade and compare reported side effects between groups (Radiation)
moderate hypo fractionation radiation therapy
PRO's of moderate hypo fractionation, 37,5 Gy in 15 or 36 Gy in 12 daily fractions administered 5 days per week.
干预措施: grade and compare reported side effects between groups (Radiation)
结局指标
主要结局
urinary toxicity analysis (IPSS)
时间窗: at 5 years
median IPSS scores will be reported post-therapy and compare between arms at 5 years post-therapy
GU toxicity analysis (CTCAE)
时间窗: at 5 years post-therapy
quantitatively evaluated using CTCAE (v5) and compare between arms
GI toxicity analysis (CTCAE)
时间窗: at 5 years post-therapy
quantitatively evaluated using CTCAE (v5) and compare between arms
sexual function analysis (SHIM)
时间窗: at 5 years
median SHIM scores will be reported post-therapy and compare between arms at 5 years post-treatment
quality of life questionnaires analysis (EPIC26)
时间窗: at 5 years
median EPIC26 scores will be reported post-therapy and compare between arms at 5 years post-treatment
次要结局
- Clinical outcomes(at 10 years)
研究者
André-Guy Martin
Clinical professor, M.D., M.Sc., F.R.C.P.C.
CHU de Quebec-Universite Laval