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Patients With Metastasized Prostate Cancer Whose Prostate-specific Antigen-level (PSA) Remains >0,2 ng/ml After Six Months of Dual Antihormonal Therapy Will Receive Radiotherapy to the Prostate and Radiotherapy to Refractory Metastases (RIALTO)

2026年6月8日 更新者：University Hospital Tuebingen

RIALTO: Radiotherapy in Primarily Metastasized Prostate Cancer - Image-guided Local AbLaTion of Prostate and Oligoresidual Disease

The goal of this clinical trial is to learn if radiotherapy to the prostate and PET-positive (positron emission tomography) metastasis will lead to radiological response on PSMA-PET (prostate specific membrane antigen-PET). Patients who receive combined androgen deprivation therapy for de novo metastasized prostate cancer and show an incomplete PSA-response (>0,2 ng/ml after six months) and exhibit at least four bone metastases on PET-imaging at this time point (without metastases to organs) can take part in this study.

The main questions it aims to answer are:

• Does radiotherapy to the prostate and PET-positive metastases lead to a radiological response one year after radiotherapy? Researchers will analyze PET-imaging prior to radiotherapy to the prostate and metastases and one yeare thereafter.

Participants will:

  • Continue taking combined androgen-deprivation therapy
  • Receive a total of three PSMA-PET/CT scans
  • Receive radiotherapy to the prostate and PET-positive metastases
  • Visit the clinic every three months for 36 months
  • Complete quality of life questionnaires at every visit

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

27

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。

学习联系方式

研究联系人备份

  • 姓名：Maximilian Niyazi, MD, Prof. Dr. Dipl.-Phys.

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:

  • Prostate adenocarcinoma
  • de novo metastasized prostate cancer (at least 4 osseous metastases +/- lymphonodal metastases)
  • first-line combined antihormonal therapy (ADT + ARPI) for six months
  • PSA > 0,2 ng/ml after six months of combined ADT/ARPI therapy
  • multimetastasized disease stage without visceral metastases on imaging at first diagnosis (PET, CT, or bone scan)
  • <16 osseous/lymphnodal metastases on response assessment imaging (PSMA-PET/CT) after six months of combined antihormonal therapy

Exclusion Criteria:

  • neuroendocrine histology
  • visceral metastases (M1c)
  • prior radiotherapy to the pelvis
  • PSA < 0,2 ng/ml after 6 months of combined antihormonal therapy
  • prior prostatectomy
  • contraindication against PSMA-PET/CT and/or radiotherapy to the prostate/metastases
  • HIFU or TUR-P within 6 months of study treatment
  • other active malignancy two years prior to study inclusion (except skin cancer in remission)
  • relevant GU/GI condition (active fistula or other)
  • known tumor predisposition syndrome

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：其他
  • 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：Radiotherapy to the prostate and PSMA-PET/CT guided radiotherapy of refractory metastases
Radiotherapy to the prostate and refractory metastases on PSMA-PET/CT
辐射：Radiotherapy to the prostate and to PSMA-PET positive metastases
Patients will receive radiotherapy to the prostate and to PSMA-PET postivie Metastases

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
Radiological Progression-Free Survival
大体时间：12 months after radiotherapy of metastases
Radiological Progression-Free Survival as determined on PSMA-PET/CT according to RECIP criteria, defined as 30% response in PSA-volume
12 months after radiotherapy of metastases

次要结果测量

结果测量
措施说明
大体时间
Lesion-specific response on imaging
大体时间：12 months after radiotherapy to metastases
12 months after radiotherapy to metastases
Prostate specific antigen (PSA)
大体时间：up to 36 months after radiotherapy to the prostate
Prostate specific antigen
up to 36 months after radiotherapy to the prostate
Objective response rate
大体时间：12 months after radiotherapy to metastases
12 months after radiotherapy to metastases
Time to next systemic therapy
大体时间：up to 36 months after radiotherapy to the prostate
up to 36 months after radiotherapy to the prostate
Overall survival
大体时间：up to 36 months after radiotherapy to the prostate
up to 36 months after radiotherapy to the prostate
Failure-free survival
大体时间：up to 36 months after radiotherapy to the prostate
up to 36 months after radiotherapy to the prostate
Progression-free survival
大体时间：up to 36 months after radiotherapy to the prostate
up to 36 months after radiotherapy to the prostate
Metastasis-free survival
大体时间：up to 36 months after radiotherapy to the prostate
up to 36 months after radiotherapy to the prostate
Prostate-cancer specific survival
大体时间：up to 36 months after radiotherapy to the prostate
up to 36 months after radiotherapy to the prostate

其他结果措施

结果测量
措施说明
大体时间
Quality of life questionnaires
大体时间：up to 36 months after radiotherapy of the prostate
EORTC QLQ-C30 Prostate
up to 36 months after radiotherapy of the prostate
Organ-specific side effects
大体时间：up to 36 months after radiotherapy of the prostate
CTCAEv5
up to 36 months after radiotherapy of the prostate
Organ function
大体时间：up to 36 months after radiotherapy of the prostate
IPS-Score
up to 36 months after radiotherapy of the prostate
Choice of next systemic therapy
大体时间：up to 36 months after radiotherapy to the prostate
Documentation of systemic treatment in case of progression
up to 36 months after radiotherapy to the prostate
Reason for change in systemic therapy
大体时间：up to 36 months after radiotherapy to the prostate
Documentation in case of change in systemic therapy
up to 36 months after radiotherapy to the prostate
Quality of Life questionnaire
大体时间：up to 36 months after end of radiotherapy of the prostate
QLQ-PR25
up to 36 months after end of radiotherapy of the prostate
Quality of life questionnaire
大体时间：up to 36 months after radiotherapy to the prostate
EQ-D5
up to 36 months after radiotherapy to the prostate
Organ-specific side effects
大体时间：up to 36 months after end of radiotherapy
RTOG questionnaire
up to 36 months after end of radiotherapy
Organ function
大体时间：up to 36 months after radiotherapy to the prostate
ICIQScore
up to 36 months after radiotherapy to the prostate
Organ-specific function
大体时间：up to 36 months after radiotherapy to the prostate
NCI-PRO-CTCAE
up to 36 months after radiotherapy to the prostate
Organ-specific function
大体时间：up to 36 months after radiotherapy to the prostate
IIEF
up to 36 months after radiotherapy to the prostate

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

University Hospital Tuebingen

合作者

Ludwig-Maximilians - University of Munich
University Hospital Freiburg
University Hospital Dresden
University Hospital Augsburg
Uniklinikum Giessen und Marburg

调查人员

  • 首席研究员：Elgin Hoffmann, MD、Department of Radiation Oncology, University Hospital Tübingen

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 (估计的)

2026年7月1日

初级完成 (估计的)

2027年7月1日

研究完成 (估计的)

2031年2月1日

研究注册日期

首次提交

2026年6月1日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月8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

其他相关的 MeSH 术语

其他研究编号

  • 430/2025BO1
  • DRKS00038018 (注册表标识符：Deutsches Register Klinischer Studien (German clinical trial registry))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Depending on national data security legislation for sharing individual data, providing IPD might not be permitted without explicit consent by the patients enrolled in this study.

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.

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