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Efficacy and Safety of Simultaneous Integrated Boost Radiotherapy in HR/VHR Prostate Cancer With EPLNI (SIB-VMAT)

2026年7月3日 更新者：Mohamed Alhefny Almashtouly、Ain Shams University

Prospective Evaluation of Efficacy and Safety of Simultaneous Integrated Boost (SIB-VMAT) Radiotherapy in HR/VHR Prostate Cancer With EPLNI

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:

  1. Acute and late gastrointestinal and genitourinary toxicities.
  2. Evaluate the efficacy in terms of early bPFS.
  3. Dosimetric evaluation in terms of target coverage and organs at risk sparing

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

Primary Endpoint: Acute and late GIT & GU toxicities (according to CTCAE & RTOG).

Secondary Endpoints:

  1. To evaluate early biochemical control (serum PSA) at 6 and 12 months.
  2. To perform a dosimetric analysis of target coverage and of organs at risk (OARs) dose contains.

Significance α = 0.05 two-sided; power = 80%; minimum detectable HR = 0.65 Duration 12 months total (from IRB approval to submission of the manuscript).

研究类型

介入性

注册 (估计的)

30

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 埃及
      • Cairo、埃及
        • 招聘中
        • Faculty of medicine, Ain Shams university
        • 接触：
      • Shibīn al Kawm、埃及
        • 招聘中
        • Faculty of Medicine - Menoufia University
        • 接触：
      • Sohag、埃及
        • 招聘中
        • Faculty of Medicine - Sohag University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prior pelvic radiotherapy.
  • History of Inflammatory Bowel Disease (IBD) or active severe proctitis.
  • Presence of distant metastases.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：SIB-VMAT radiation therapy

Patients with histopathologically confirmed prostatic adenocarcinoma staged as high-risk / very high-risk localized disease will receive radiotherapy using Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT) over a total duration of 4 weeks (20 consecutive working days).

Target volumes:

PTV-1 (PTV 44 Gy) Prostate + Pelvic Lymph Node PTV (PLNI): 44 Gy delivered in 20 fractions (2.2 Gy/fraction), including the internal iliac, external iliac, obturator, presacral nodal stations, whole prostate, and SV.

PTV-2 (PTV 60 GY): 60 Gy delivered in 20 fractions (3 Gy/fraction), including the whole prostate and the base of the SV (proximal 1 cm).

Systemic Therapy is allowed during the study when indicated. Patients will receive long-term Androgen Deprivation Therapy (ADT) for a duration of 18-24 months. ADT will be initiated as neoadjuvant therapy 2-3 months prior to the commencement of radiotherapy.
辐射：Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT)
Patients with histopathologically confirmed prostatic adenocarcinoma staged as high-risk / very high-risk localized disease will receive radiotherapy using Simultaneous Integrated Boost Volumetric Modulated Arc Therapy (SIB-VMAT) over a total duration of 4 weeks (20 consecutive working days). Target volumes: PTV-1 (PTV 44 Gy) Prostate + Pelvic Lymph Node PTV (PLNI): 44 Gy delivered in 20 fractions (2.2 Gy/fraction), including the internal iliac, external iliac, obturator, presacral nodal stations, whole prostate, and SV. PTV-2 (PTV 60 GY): 60 Gy delivered in 20 fractions (3 Gy/fraction), including the whole prostate and the base of the SV (proximal 1 cm). Systemic Therapy is allowed during the study when indicated. Patients will receive long-term Androgen Deprivation Therapy (ADT) for a duration of 18-24 months. ADT will be initiated as neoadjuvant therapy 2-3 months prior to the commencement of radiotherapy.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Acute and late GIT & GU toxicity
大体时间：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.
Day 1, Day 7, Day 14, Day 20 from radiation therapy start, then week 4, week 8, week 12 from radiation therapy end.

次要结果测量

结果测量
措施说明
大体时间
Early biochemical progression-free survival (bPFS)
大体时间：Day 1, Month 3, Month 6 and Month 12, from radiation therapy end.
Early biochemical control in terms of the serial measurement of serum PSA levels.
Day 1, Month 3, Month 6 and Month 12, from radiation therapy end.
Dosimetric plan evaluation
大体时间：Baseline (Day 1 of radiation therapy start).
  1. Dosimetric analysis of planning target volume coverage (PTV ): at least 95% of the volume must be covered with 95% of the prescribed radiation dose.
  2. Dosimetric analysis of organs at risk (OAR) dose constraints, including rectum, urinary bladder, bowel, femoral heads, and penile bulb radiation doses, according to Quantec and Chipp trial dose constraints.
Baseline (Day 1 of radiation therapy start).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ain Shams University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年8月1日

初级完成 (估计的)

2026年9月1日

研究完成 (估计的)

2026年11月1日

研究注册日期

首次提交

2026年6月28日

首先提交符合 QC 标准的

2026年7月3日

首次发布 (实际的)

2026年7月9日

研究记录更新

最后更新发布 (实际的)

2026年7月9日

上次提交的符合 QC 标准的更新

2026年7月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • Soh-Med-26-6-12PD

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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