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大分割图像引导放射治疗 (IGRT) 与器官运动缓解和尿道保留治疗前列腺癌

2026年5月7日 更新者：Carlo Greco, MD、Fundacao Champalimaud

本研究评估了对局限于器官的前列腺腺癌患者进行确定性超高剂量每次外照射放射治疗后的临床结果。

参加该研究的患者将接受图像引导的体积强度调制弧形放射治疗 (IGRT-VMAT)，采用最先进的治疗计划和质量保证程序，重点是通过使用确保稳定性和光束位置再现性的装置。 一个充满空气的直肠气球将用于前列腺目标固定和解剖学可重复性，而装有信标转发器的导尿管将用于确保设置可重复性和在线目标跟踪。 先前未经治疗的前列腺癌患者将在连续 5 天内接受 45 Gy 的治疗，分五次 9 Gy。

患者将在治疗后一个月进行随访，每 3 个月一次，最长 12 个月（+/- 4 周），此后每 6 个月（+/- 6 周）一次。 急性和晚期毒性评估将重点（但不限于）泌尿、直肠和性功能，并将通过经过验证的扩展前列腺癌综合指数 (EPIC)、国际前列腺症状评分 (IPSS) 和国际勃起功能指数 (IIEF) 进行评估问卷。 血清前列腺特异性抗原 (PSA) 值将按照与临床随访相同的时间表得出。 患者将被持续监测至少 5 年。

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a prospective, single-arm phase II study of definitive ultra-hypofractionated image-guided radiotherapy for localized prostate adenocarcinoma. The study is designed to evaluate the acute and late safety profile, feasibility, patient-reported quality-of-life outcomes, PSA kinetics, biochemical relapse-free survival, and clinical outcomes of dose-escalated IGRT-VMAT using organ-motion mitigation and urethral sparing.

Patients will receive 45 Gy in 5 fractions of 9 Gy each. Treatment planning will use CT/MRI-based target and organ-at-risk delineation. The protocol incorporates a rectal balloon for prostate stabilization and anatomical reproducibility, a urethral catheter loaded with beacon transponders for urethral localization and online motion tracking, and inverse dose-painting to reduce urethral dose when compatible with target coverage and disease anatomy. Erectile-related structures, including the neurovascular bundles, urogenital diaphragm, and penile bulb, may be contoured and recorded for quality-of-life and dosimetric analyses.

The primary safety assessments are treatment-related Grade 3 or higher gastrointestinal or genitourinary toxicity occurring from the first protocol fraction through 90 days after treatment completion, and treatment-related late Grade 2 or higher gastrointestinal or genitourinary toxicity occurring more than 90 days through 5 years after completion of radiotherapy. Late Grade 3 or higher gastrointestinal or genitourinary toxicity will be summarized separately. Clinically meaningful deterioration from baseline in urinary, bowel, and sexual patient-reported outcomes will be evaluated as a key safety and quality-of-life assessment.

Secondary assessments include PSA kinetics, biochemical relapse-free survival using the Phoenix definition, quality-of-life changes measured by EPIC, IPSS, and IIEF instruments, erectile and sexual function preservation, associations between clinical or dosimetric factors and outcomes, hormonal therapy exposure, and patterns of recurrence on clinically indicated imaging.

研究类型

介入性

注册 (实际的)

444

阶段

  • 不适用

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。

学习地点

  • 葡萄牙
      • Lisbon、葡萄牙、1400-038
        • Champalimaud Foundation

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

40年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 签署研究特定知情同意书；
  • 通过活检对前列腺腺癌进行组织学确认；
  • 以前的激素治疗是允许的（但不是必需的）；
  • 经过适当的分期研究后，没有区域或远处转移的直接证据；
  • 年龄≥40；
  • 绩效状态 0-2；
  • 美国泌尿协会 (AUA) 评分必须≤ 20（允许使用α受体阻滞剂）；
  • 计算机断层扫描 (CT) 或基于超声的前列腺体积估计 ≤ 150 克。

排除标准：

  • 影像学研究中前列腺癌转移性疾病的 MRI 影像学证据 T3、T4；
  • 既往盆腔放疗；
  • 既往前列腺癌手术；
  • 治疗前接受激素治疗超过 6 个月；
  • 克罗恩病或溃疡性结肠炎病史；
  • 以前有明显的阻塞症状；
  • 重大精神疾病；
  • 第 3 节中定义的严重、活跃的合并症。

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：Experimental: Ultra-hypofractionated IGRT-VMAT 45 Gy in 5 fractions of 9 Gy
Participants will receive definitive dose-escalated image-guided volumetric modulated arc radiotherapy for localized prostate adenocarcinoma. Radiotherapy will be delivered to 45 Gy in 5 fractions of 9 Gy each over 5 consecutive days, using organ-motion mitigation, urethral localization, online target tracking, urethral sparing, rectal balloon stabilization, and protocol-specified treatment planning and quality assurance procedures.
设备：充气直肠气球
充气的直肠球囊将用于前列腺靶标固定和解剖再现性。
设备：装有信标转发器的导尿管
装有信标转发器的导尿管将用于确保设置的可重复性和在线目标跟踪。
辐射：Ultra-hypofractionated IGRT-VMAT with organ-motion mitigation and urethral sparing
Image-guided volumetric modulated arc radiotherapy delivered to 45 Gy in 5 fractions of 9 Gy each. Treatment uses CT/MRI-based planning, a rectal balloon for target immobilization and anatomical reproducibility, a urethral catheter loaded with beacon transponders for localization and online tracking, and urethral dose sparing using inverse dose-painting when compatible with target coverage and disease anatomy.

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 treatment-related Grade ≥3 gastrointestinal or genitourinary toxicity
大体时间：From first protocol fraction through 90 days after completion of radiotherapy
Incidence of treatment-related Grade 3 or higher gastrointestinal or genitourinary adverse events, graded using NCI CTCAE version 4.0.
From first protocol fraction through 90 days after completion of radiotherapy
Late treatment-related Grade ≥2 gastrointestinal or genitourinary toxicity
大体时间：More than 90 days through 60 months after completion of radiotherapy
Incidence of treatment-related late Grade 2 or higher gastrointestinal or genitourinary adverse events, graded using NCI CTCAE version 4.0. Late Grade 3 or higher toxicity will be summarized separately.
More than 90 days through 60 months after completion of radiotherapy

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in urinary quality of life
大体时间：Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Change in urinary symptoms and urinary quality-of-life domains using validated instruments including EPIC-26 and IPSS. Change from baseline in EPIC-26 and IPSS, . The EPIC-26 (Expanded Prostate Cancer Index Composite score) questionnaire ranges between 0 and 100, with higher values indicating better quality of life. The IPSS (International Prostatic Symptoms Score) questionnaire ranges between 0 and 35 with higher values indicating worse urinary symptoms.
Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Change from baseline in bowel quality of life
大体时间：Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Change in bowel/rectal patient-reported outcomes using EPIC bowel-domain assessments. The EPIC-26 (Expanded Prostate Cancer Index Composite score) questionnaire ranges between 0 and 100, with higher values indicating better quality of life.
Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Change from baseline in sexual function
大体时间：Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Change in sexual function and sexual quality of life using EPIC-26 sexual-domain and IIEF instruments. The EPIC-26 (Expanded Prostate Cancer Index Composite score) questionnaire ranges between 0 and 100, with higher values indicating better quality of life. The IIEF (International Index of Erectile Function) questionnaire ranges between 0 and 30 with higher scores indicating better sexual function.
Baseline; approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
PSA kinetics after radiotherapy
大体时间：Approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Longitudinal serum PSA values after treatment, including PSA decline patterns and association with clinical outcomes.
Approximately 1, 3, 6, 9, and 12 months; then every 6 months through 60 months
Biochemical relapse-free survival
大体时间：Through 60 months or longer after completion of radiotherapy
Time to biochemical relapse, assessed using the Phoenix definition.
Through 60 months or longer after completion of radiotherapy
Patterns of recurrence
大体时间：Through 60 months or longer after completion
Local, nodal, or distant recurrence patterns summarized from clinically indicated imaging at or after biochemical relapse.
Through 60 months or longer after completion
Correlation of clinical and dosimetric variables with toxicity and quality-of-life outcomes (EPIC-26)
大体时间：Through 60 months after completion of radiotherapy
Analysis of correlations between treatment-planning dose metrics, clinical factors, toxicity, and EPIC-26 patient-reported outcomes. EPIC-26 (Expanded Prostate Cancer Index Composite score) questionnaire ranges between 0 and 100, with higher values indicating better quality of life.
Through 60 months after completion of radiotherapy

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

Fundacao Champalimaud

调查人员

  • 首席研究员：Carlo Greco, MD、Fundacao Champalimaud

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2013年5月1日

初级完成 (实际的)

2025年12月30日

研究完成 (实际的)

2025年12月30日

研究注册日期

首次提交

2016年4月26日

首先提交符合 QC 标准的

2016年5月2日

首次发布 (估计的)

2016年5月4日

研究记录更新

最后更新发布 (实际的)

2026年5月12日

上次提交的符合 QC 标准的更新

2026年5月7日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HYPO

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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