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雄激素抑制的前列腺癌患者的靶向放射治疗。 (TRAP)

2026年4月22日 更新者：Royal Marsden NHS Foundation Trust

TRAP - 雄激素抑制的前列腺癌患者的靶向放射治疗。

这项多中心 II 期试验将在患有去势抵抗性前列腺癌的男性中进行。 TRAP 试验的目的是测试一种称为立体定向体部放射治疗 (SBRT) 的新型精确放射治疗技术是否可以减缓转移性前列腺癌的生长。 如果 SBRT 有效，它将代表这些患者的新治疗选择，提供更长时间的控制，而不必求助于化学疗法及其潜在的令人不快的副作用。

在这项试验中，研究人员将确定尽管接受了下一代雄激素剥夺治疗（阿比特龙或恩杂鲁胺）已经出现一个或两个新的恶化（生长）疾病部位但其余癌症仍对激素治疗有反应的男性。 如果 SBRT 能够成功治疗对当前治疗有抵抗力的癌症，那么研究人员希望他们能够更好地控制癌症在这些患者中的扩散更长时间。

研究人员还希望他们能够使用释放到这些患者血液中的告密产品（基因标记），或识别磁共振成像 (MRI) 等新型成像的特征，以帮助识别患者未来谁受益最大。

研究概览

地位

完全的

条件

干预/治疗

详细说明

对于许多患有转移性前列腺癌的男性来说，癌症对连续的全身治疗产生了耐药性，最终所有的治疗选择都用尽了，患者死于疾病。 因此，找到逃避前列腺癌耐药性的方法至关重要。 立体定向放疗 (SBRT) 的优势在于它可以破坏癌变组织，而不管进行性转移中的潜在遗传缺陷如何。 如果耐药克隆定位于 1-2 个转移灶并且可以被破坏或消融，则患者可以继续接受全身（雄激素剥夺）治疗（阿比特龙或恩杂鲁胺）的益处，这可能会继续控制其剩余的疾病好几个月，甚至好几年。

SBRT 是一种公认​​的消除其他肿瘤部位孤立转移的技术，可在 80-90% 的病例中实现对转移的局部控制。 这是在几乎没有副作用的情况下实现的。 在 TRAP 试验中，研究人员希望确定用 SBRT 靶向 1 或 2 个转移部位是否有益，或者患者是否会发展为多转移进展。 参加试验的患者将在 10 天内隔天接受 30 Gy 的 5 次照射。 他们将在 SBRT 期间和之后继续他们的雄激素剥夺治疗。 副作用将在整个过程中受到密切监测，患者将在放疗结束时和治疗后 4 周进行观察。 此后，患者将接受三个月的试验跟进，其中包括前列腺特异性抗原 (PSA) 监测。

除了上述程序外，研究人员还将结合使用全身 (WB) 弥散加权 (DW) 磁共振成像 (WB DW MRI) 和循环肿瘤 (ct) 脱氧核糖核酸 (DNA)、“ct DNA”生物标志物分析目的是确定那些从 SBRT 和雄激素剥夺治疗的组合中获益最多的患者。 WB DW MRI 是一种新型 MRI 技术，与标准 MRI 相比，它显示出更高的灵敏度。 标记 ctDNA 使研究人员能够探索基因组特征和转移的变异，并将发现与先前探索的前列腺癌患者的基因组突变进行比较。

研究类型

介入性

注册 (实际的)

86

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

  • 英国
    • Manchester Greater
      • Manchester、Manchester Greater、英国、M20 4BX
        • The Christie NHS Foundation Trust
    • Northern Ireland
      • Belfast、Northern Ireland、英国、BT8 8BH
        • Belfast Health & Social care Trust
    • Surrey
      • Sutton、Surrey、英国、SM5 3EZ
        • Angelie Tirona
    • Tyne and Wear
      • Newcastle upon Tyne、Tyne and Wear、英国、NE7 7DN
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    • Wales
      • Cardiff、Wales、英国、CF14 2TL
        • Velindre Cancer Centre
    • West Midlands
      • Birmingham、West Midlands、英国、B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust
    • West Yorkshire
      • Leeds、West Yorkshire、英国、LS9 7TF
        • Leeds Teaching Hospitals NHS Trust

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

14年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  1. 愿意并能够为试验提供书面知情同意书，并且在签署知情同意书之日年满 18 岁。
  2. 根据生化或病理诊断患有转移性去势抵抗性前列腺癌 (CRPC)，并且正在服用恩杂鲁胺或阿比特龙。
  3. 已服用恩杂鲁胺或阿比特龙至少 6 个月并有反应证据（PSA、放射学或症状）
  4. 有 1-2 个转移性病灶在影像学（CT、骨扫描、MRI 或其他局部影像学）上进展，或临床或影像学诊断为未受照射的原发部位进展，其转移的其余部分目前由 Enzalutamide 或 Abiraterone 控制。
  5. 之前没有对指标区域进行过根治性辐射（定义为在不使正常组织超出耐受范围的情况下无法在本协议中提供 SBRT 剂量）。
  6. 使用 0 - 1 的东部合作肿瘤组 (ECOG) 标准评估绩效状态 (PS)。
  7. 在骨骼、淋巴结、前列腺或肺中有寡聚进展部位，包括在治疗中出现的部位，但不在肝脏、大脑、肾上腺或其他部位。
  8. 患者可能在寡进展区出现症状。 但是，并不迫切需要开始放疗。

排除标准：

  1. 存在立即转换治疗的临床需要（例如 怀疑快速临床进展，迫切需要姑息性放疗）。
  2. 过去 5 年内曾患浸润性癌症的证据，非黑色素瘤皮肤癌除外（不排除非浸润性恶性肿瘤，如非肌肉浸润性膀胱癌）。
  3. 放疗有禁忌症（例如 炎症性肠病）。
  4. 如果需要放疗（例如 心脏起搏器、体内除颤器、弹片伤害或幽闭恐惧症）。

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：SBRT + ADT
许可剂量的恩杂鲁胺或阿比特龙联合立体定向放疗：30 Gray，分 5 次
辐射：SBRT + ADT
除了继续使用阿比特龙或恩杂鲁胺外，对 1 或 2 个寡核苷酸进展性转移进行短期 SBRT
其他名称：
  • 恩杂鲁胺或阿比特龙联合立体定向放疗

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
Median Progression-Free Survival (PFS)
大体时间：Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).

Median progression free survival following SBRT to progression, starting new treatment or death from any cause.

Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.
Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).

次要结果测量

结果测量
措施说明
大体时间
Progression-Free Survival (PFS) Events
大体时间：Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).

Number of patients that had a PFS event following SBRT in the duration of the study. Progression free survival definition is time from SBRT to progression, starting new treatment or death from any cause.

Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.
Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Progression-Free Survival (PFS) Estimates
大体时间：Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).

Progression free survival estimates following SBRT to progression, starting new treatment or death from any cause.

Progression is defined as one of the following; (i) PSA progression: PSA rise by at least 25% over post-SBRT baseline (set at 4 weeks), confirmed by a second reading at least 4 weeks later, (ii) Radiological progression: at least 2 new lesions on bone scan or unequivocal progression of soft tissue on CT, or evidence on other local imaging of disease progression (e.g. PET or MRI progression) as per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) (iii) Symptomatic progression: new or progressing symptoms at the site of a metastasis, or (iv) Date at which the clinician decides to stop Abiraterone/Enzalutamide or starts new line of therapy, whichever occurs sooner.
Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Local Control Rate Following SBRT
大体时间：At the 6 month timepoint from end of SBRT
Overall control defined as stable disease or partial response of irradiated metastases assessed using the RECIST (v 1.1) criteria on imaging such as computed Tomography (CT), magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scan or control on bone scan
At the 6 month timepoint from end of SBRT
Median Overall Survival (OS)
大体时间：Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Median OS following SBRT until death from any cause.
Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Overall Survival (OS) Events
大体时间：Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Number of patients who had an OS event following SBRT in the duration of the study. Overall survival definition is time from SBRT to death from any cause.
Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Overall Survival (OS) Estimates
大体时间：Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
OS estimates following SBRT to death from any cause.
Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Median Time to Administration of Next Line of Therapy or Death
大体时间：Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Median time following SBRT to alternative therapy administration or death.
Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Administration of Next Line of Therapy or Death Events
大体时间：Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Number of patients that started new treatment or died following SBRT in the duration of the study.
Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Time to Administration of Next Line of Therapy or Death
大体时间：Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Time estimates from SBRT to alternative therapy administration or death.
Time on study (up to 24 months from the end of SBRT, with further follow-up after 24 months if patient data were available).
Health Related Quality of Life
大体时间：Up to 12 months from the end of SBRT
Patient Reported Quality of Life assessed using the EuroQol (EQ) EQ-5D-5L questionnaire. VAS scale is from 0-100. A higher VAS score indicates better quality-of-life. Outcome data has been reported for (i) all completed assessments and for (ii) assessments conducted up to the point of disease progression, in order to exclude the potential influence of progression on quality-of-life outcomes.
Up to 12 months from the end of SBRT
Number of Participants With Incidence and Severity of Treatment Induced Symptoms (RTOG)
大体时间：Up to 24 months from the end of SBRT
Severity of acute and late side-effects resulting from SBRT assessed using the RTOG (Radiation Therapy Oncology Group) scoring criteria. A higher RTOG grade suggests higher severity of symptoms. Overall maximum grade for each patient at each timepoint is reported.
Up to 24 months from the end of SBRT
Number of Participants With Incidence and Severity of Treatment Induced Symptoms (CTCAE)
大体时间：Up to 24 months from the end of SBRT
Severity of acute and late side-effects resulting from SBRT assessed using the Common Terminology Criteria for Adverse Events (CTCAE). A higher CTCAE grade suggests higher severity of symptoms. Overall maximum grade for each patient at each timepoint is reported.
Up to 24 months from the end of SBRT
Prostate Specific Antigen (PSA) Values
大体时间：Up to 12 months from the end of SBRT
Prostate Specific Antigen (PSA) values recorded post-SBRT
Up to 12 months from the end of SBRT

其他结果措施

结果测量
措施说明
大体时间
探索新的生物标志物以评估对 SBRT 治疗的反应
大体时间：评估 6 个月和 1 年的无进展生存期
循环肿瘤脱氧核糖核酸 (ctDNA) 水平
评估 6 个月和 1 年的无进展生存期

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

Royal Marsden NHS Foundation Trust

合作者

University College, London
The Leeds Teaching Hospitals NHS Trust
Belfast Health and Social Care Trust
University Hospital Birmingham NHS Foundation Trust
Newcastle-upon-Tyne Hospitals NHS Trust
The Christie NHS Foundation Trust
Velindre NHS Trust
Prostate Cancer UK

调查人员

  • 首席研究员：Alison Tree, FRCR、Royal Marsden NHS Foundation Trust

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)

2018年8月13日

初级完成 (实际的)

2025年3月31日

研究完成 (实际的)

2025年3月31日

研究注册日期

首次提交

2018年8月15日

首先提交符合 QC 标准的

2018年8月21日

首次发布 (实际的)

2018年8月23日

研究记录更新

最后更新发布 (实际的)

2026年5月14日

上次提交的符合 QC 标准的更新

2026年4月22日

最后验证

2026年4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

  • CCR 4781

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

如果患者知情同意，多余的人体组织（血液）将可用于其他符合伦理的研究

IPD 共享时间框架

预计在招募最后一名患者后 6 个月内不会发生。

IPD 共享访问标准

根据书面要求

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

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

SBRT + ADT的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Mongolia

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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