PRISTINE Trial: PRoton Beam Therapy In Seminoma - Toxicity INvestigation and Evaluation of Outcome (PRISTINE)
2026年5月15日 更新者：Istituto Clinico Humanitas
Stage II seminoma is a type of cancer that is usually highly curable and most often affects young men.
Radiotherapy is an effective treatment, but it can sometimes cause side effects in the long term and, rarely, increase the risk of developing another cancer later in life.For this reason, more targeted treatments are being explored, such as proton therapy (PBT). This type of radiotherapy uses protons to better focus the treatment on the tumor while reducing exposure to the surrounding healthy tissues.The goal is to treat the cancer effectively while minimizing side effects as much as possible.
研究概览
研究类型
介入性
注册 (估计的)
20
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
- 姓名：Ciro Franzese, MD, Radiation Oncologist
- 电话号码：+39 0282247454
- 邮箱：ciro.franzese@hunimed.eu
研究联系人备份
- 姓名：Laura Bonavita, Master degree
- 电话号码：+39 0282247026
- 邮箱：laura.bonavita@humanitas.it
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:
- Age ≥ 18 years
- Male gender
- ECOG Performance status 0 - 1
- Histologically confirmed diagnosis of testicular seminoma
- Stage IIA - IIB disease with metastatic involvement limited to retroperitoneal lymph nodes measuring ≤3 cm in greatest diameter
- Prior radical orchiectomy
- Clinical indication for radiotherapy
- Written informed consent provided
Exclusion Criteria:
- Non-seminomatous germ cell tumor histology
- Incomplete definitive surgical orchiectomy, including diagnostic biopsy alone
- Prior or concurrent second malignancy other than non-melanoma skin cancer, unless disease free for a minimum of five years
- Prior radiotherapy to the abdominal or pelvic region
- Known severe, active co-morbidity
- Inability or refusal to provide informed consent
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：Protontherapy Treatment
patient will be treated with protontherapy instead of radiotherapy
|
patients will be treated with protontherapy instead of radiotherapy with photon as standard of care
|
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 |
|---|---|---|
|
Treatment toxicities
大体时间：from enrollment to two years follow up
|
Incidence of Grade ≥2 late treatment-related toxicity defined according to CTCAE v6.0 criteria
|
from enrollment to two years follow up
|
|
Progression free survival
大体时间：from enrollment to 12 months from treatment
|
Progression free survival within 12 months after radiotherapy defined defined as radiological progression and/or biochemical evidence of relapse, or death from any cause.
|
from enrollment to 12 months from treatment
|
|
Modeled excess absolute risk (EAR) of secondary malignancies
大体时间：from treatment to two years follow up
|
estimated from individual organ dosimetry using validated dose-response models (exploratory, model-based component)
|
from treatment to two years follow up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall survival
大体时间：from treatment to three years follow up
|
Overall survival at 3 years post-treatment defined by survival status of patients at each time point
|
from treatment to three years follow up
|
|
Quality of life outcomes
大体时间：from treatment to two years follow up
|
evaluation of quality of life of patients through the completion of questionnarie QLQ-C30.
Question with a scale from 1 to 4 (1 low quality of life - 4 high quality of life)
|
from treatment to two years follow up
|
|
Values of circulating hsa-miR-371a-3p in patient treated with Proton Therapy
大体时间：from treatment to two years follow up
|
Evaluation of the change in circulating hsa-miR-371a-3p concentration (mg/dL) before and after experimental treatment.
This tumor marker is being investigated as a potential biomarker for the early diagnosis of testicular cancer, and the aim is to analyze how it may be influenced by proton therapy by comparing it with standardized reference values.
|
from treatment to two years follow up
|
|
Correlation between miRNA clearance/persistance and outcomes
大体时间：from treatment to two years follow up
|
analysis of plasma samples to evaluate the concentration of miRNA in plasma and how this could be linked to treatment outcomes
|
from treatment to two years follow up
|
|
Quantification of immune cell populations according to cell type
大体时间：from treatment to two years follow up
|
Evaluation of of systemic immune modulation through the analysis of concentration in plasma samples of immune cells
|
from treatment to two years follow up
|
|
Quality of life outcomes
大体时间：from treatment to two years follow up
|
evaluation of quality of life of patients through the completion of questionnarie QLQ-TC26.
Question with a scale from 1 to 4 (1 low quality of life - 4 high quality of life).
|
from treatment to two years follow up
|
|
Quality of life outcomes
大体时间：From treatment to two years follow up
|
evaluation of quality of life of patients through the completion of questionnarie QLQ-AYA.
Question with a scale from 1 to 4 (1 low quality of life - 4 high quality of life).
|
From treatment to two years follow up
|
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。
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
- Aziz Z, Wagner S, Agyekum A, Pumpalova YS, Prest M, Lim F, Rustgi S, Kastrinos F, Grady WM, Hur C. Cost-Effectiveness of Liquid Biopsy for Colorectal Cancer Screening in Patients Who Are Unscreened. JAMA Netw Open. 2023 Nov 1;6(11):e2343392. doi: 10.1001/jamanetworkopen.2023.43392.
- Marelli G, Morina N, Puccio S, Iovino M, Pandini M, Portale F, Carvetta M, Mishra D, Diana E, Meregalli G, Paraboschi E, Cibella J, Peano C, Basso G, De Simone G, Camisaschi C, Magrini E, Sartori G, Karimi E, Colombo P, Lazzeri M, Casale P, Morosi L, Martano G, Asselta R, Bonavita E, Matsunami H, Bertoni F, Walsh L, Lugli E, Di Mitri D. Chemosensor receptors are lipid-detecting regulators of macrophage function in cancer. Nat Immunol. 2025 Jul;26(7):1182-1197. doi: 10.1038/s41590-025-02191-x. Epub 2025 Jun 30.
- Li X, Ding R, Liu Z, Teixeira WMS, Ye J, Tian L, Li H, Guo S, Yao K, Ma Z, Liu Z. A predictive system comprising serum microRNAs and radiomics for residual retroperitoneal masses in metastatic nonseminomatous germ cell tumors. Cell Rep Med. 2024 Dec 17;5(12):101843. doi: 10.1016/j.xcrm.2024.101843. Epub 2024 Dec 12.
- Alsyouf M, Nappi L, Nichols C, Daneshmand S. Plasma Micro-RNA 371 Expression in Early-Stage Germ Cell Tumors: Are We Ready to Move Toward Biology-Based Decision Making? J Clin Oncol. 2023 May 10;41(14):2478-2482. doi: 10.1200/JCO.22.02002. Epub 2023 Feb 9. No abstract available.
- Konneh B, Lafin JT, Howard J, Gerald T, Amini A, Savelyeva A, Woldu SL, Lewis CM, Jia L, Margulis V, Coleman N, Scarpini C, Frazier AL, Murray MJ, Amatruda JF, Bagrodia A. Evaluation of miR-371a-3p to predict viable germ cell tumor in patients with pure seminoma receiving retroperitoneal lymph node dissection. Andrology. 2023 May;11(4):634-640. doi: 10.1111/andr.13317. Epub 2022 Nov 2.
- Nestler T, Schoch J, Belge G, Dieckmann KP. MicroRNA-371a-3p-The Novel Serum Biomarker in Testicular Germ Cell Tumors. Cancers (Basel). 2023 Aug 3;15(15):3944. doi: 10.3390/cancers15153944.
- Tulik P, Maciak M, Tulik M. A dosimetric comparison of 3D-CRT, IMRT and IMAT treatment techniques - assessment from radiation protection point of view. Rep Pract Oncol Radiother. 2024 Mar 18;29(1):69-76. doi: 10.5603/rpor.99025. eCollection 2024.
- Pursley J, Remillard K, Depauw N, Lee G, Grassberger C, Paganetti H, Efstathiou JA, Kamran SC. Radiation Therapy for Stage IIA/B Seminoma: Modeling Secondary Cancer Risk for Protons and VMAT versus 3D Photons. Cancers (Basel). 2024 Feb 15;16(4):784. doi: 10.3390/cancers16040784.
- Maxwell R, Chang Y, Paul C, Vaughn DJ, Christodouleas JP. Cancer Control, Toxicity, and Secondary Malignancy Risks of Proton Radiation Therapy for Stage I-IIB Testicular Seminoma. Adv Radiat Oncol. 2023 May 2;8(5):101259. doi: 10.1016/j.adro.2023.101259. eCollection 2023 Sep-Oct.
- Ronde HS, Kronborg C, Hoyer M, Hansen J, Bak ME, Agergaard SN, Als AB, Agerbaek M, Lauritsen J, Meidahl Petersen P, Dysager L, Kallehauge JF. Dose comparison of robustly optimized intensity modulated proton therapy (IMPT) vs IMRT and VMAT photon plans for testicular seminoma. Acta Oncol. 2023 Oct;62(10):1222-1229. doi: 10.1080/0284186X.2023.2254925. Epub 2023 Sep 8.
- Xiang M, Chang DT, Pollom EL. Second cancer risk after primary cancer treatment with three-dimensional conformal, intensity-modulated, or proton beam radiation therapy. Cancer. 2020 Aug 1;126(15):3560-3568. doi: 10.1002/cncr.32938. Epub 2020 May 19.
- Giannatempo P, Nicolai N. What is the best way to treat patients with stage IIA or IIB seminoma? Lancet Oncol. 2022 Nov;23(11):1349-1350. doi: 10.1016/S1470-2045(22)00625-8. Epub 2022 Oct 10. No abstract available.
- Classen J, Schmidberger H, Meisner C, Souchon R, Sautter-Bihl ML, Sauer R, Weinknecht S, Kohrmann KU, Bamberg M. Radiotherapy for stages IIA/B testicular seminoma: final report of a prospective multicenter clinical trial. J Clin Oncol. 2003 Mar 15;21(6):1101-6. doi: 10.1200/JCO.2003.06.065.
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5月1日
初级完成 (估计的)
2031年5月1日
研究完成 (估计的)
2031年5月1日
研究注册日期
首次提交
2026年4月24日
首先提交符合 QC 标准的
2026年5月15日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年5月22日
上次提交的符合 QC 标准的更新
2026年5月15日
最后验证
2026年5月1日
更多信息
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.