Prospective Evaluation of Efficacy and Safety of Simultaneous Integrated Boost (SIB-VMAT) Radiotherapy in HR/VHR Prostate Cancer With EPLNI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Acute and late GIT & GU toxicity
研究概览
简要总结
The aim of this study is to evaluate the efficacy and safety of hypofractionated simultaneous integrated boost volumetric arc radiation therapy (SIB - VMAT) for high-risk and very high-risk localized prostate cancer in terms of:
- Acute and late gastrointestinal and genitourinary toxicities.
- Evaluate the efficacy in terms of early bPFS.
- Dosimetric evaluation in terms of target coverage and organs at risk sparing
详细描述
Background:
Despite the overwhelming success of hypofractionation for prostate-only radiotherapy, a substantial gap in high-level evidence exists regarding its application to elective pelvic lymph node irradiation. The pivotal trials establishing the 60 Gy/20 fraction standard (such as CHHiP and PROFIT) largely excluded extensive whole pelvic nodal irradiation. Consequently, there remains a lack of definitive, prospective data validating the safety and efficacy of a hypofractionated Simultaneous Integrated Boost (SIB) technique that concurrently delivers 44 Gy to the pelvic lymph nodes and 60 Gy to the prostate over 20 fractions. While modern image-guided, Volumetric Modulated Arc Therapy (VMAT) provides the dosimetric conformity required to spare organs at risk (OARs) such as the bladder and bowel, clinical confirmation of acute and late toxicities in the context of wide-field pelvic irradiation remains paramount.
Therefore, this prospective, single-arm trial is designed to address this critical evidence gap. By rigorously evaluating the GI and GU toxicity profiles and early biochemical control, this study seeks to validate the 4-week SIB protocol as a safe, efficacious, and resource-efficient standard of care for high-risk prostate cancer requiring elective pelvic nodal irradiation.
Objectives:
To evaluate the safety of hypofractionated SIB - VMAT radiation therapy in terms of acute and late GI and GU toxicities, and also evaluate the efficacy in terms of early bPFS, and lastly, dosimetric evaluation in terms of target coverage and OAR sparing Study Arms Single arm Population: Histologically confirmed localized prostatic adenocarcinoma with high and very high risk groups.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the prostate.
- •Classification as High-Risk (HR) or Very High-Risk (VHR) per NCCN guidelines (e.g., T3a+, PSA > 20 ng/mL, or Gleason Score 8-10).
- •Adequate baseline urinary function (IPSS \le 20).
- •Multiparametric MRI of the prostate.
- •CT Chest, Abdomen, and Pelvis.
- •Bone scan
- •Optional: PSMA-PET/CT to definitively exclude distant metastases (M1) and provide high-fidelity nodal assessment prior to treatment planning.
排除标准
- •Prior pelvic radiotherapy.
- •History of Inflammatory Bowel Disease (IBD) or active severe proctitis.
- •Presence of distant metastases.
结局指标
主要结局
Acute and late GIT & GU toxicity
时间窗: Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.
The incidence and severity of acute (during the radiation treatment and up to 3 months post-treatment) and late (after 3 months from finishing radiotherapy) gastrointestinal (GI) and genitourinary (GU) toxicities associated with the SIB-VMAT approach using CTCAE v5.0 and RTOG scale.
次要结局
- Early biochemical progression-free survival (bPFS)(Day 1, Month 3, Month 6 and Month 12, from radiation therapy end.)
- Dosimetric plan evaluation(Baseline (Day 1 of radiation therapy start).)
研究者
Mohamed Alhefny Almashtouly
Lecturer
Ain Shams University