PRISTINE Trial: PRoton Beam Therapy In Seminoma - Toxicity INvestigation and Evaluation of Outcome

NCT07601672 | Not Yet Recruiting

• 2 other identifiers: PRO - 2026 - 001IG 2025 ID 32742
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Seminoma

Keywords

seminoma; cancer treatment; protontherapy; radiotherapy

Outcome Measures

Primary Outcomes (3)

• Treatment toxicities

  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

  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

  estimated from individual organ dosimetry using validated dose-response models (exploratory, model-based component)

  from treatment to two years follow up

Secondary Outcomes (7)

• Overall survival

  from treatment to three years follow up

• Quality of life outcomes

  from treatment to two years follow up

• Values of circulating hsa-miR-371a-3p in patient treated with Proton Therapy

  from treatment to two years follow up

• Correlation between miRNA clearance/persistance and outcomes

  from treatment to two years follow up

• Quantification of immune cell populations according to cell type

  from treatment to two years follow up

Study Arms (1)

Protontherapy Treatment

EXPERIMENTAL

patient will be treated with protontherapy instead of radiotherapy

Radiation: protontherapy

Interventions

protontherapy RADIATION

patients will be treated with protontherapy instead of radiotherapy with photon as standard of care

Protontherapy Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• AIRC (Italian Association for Cancer Research): collaborator

Related Publications (13)

• 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.

  PMID: 40588561 BACKGROUND

• 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.

  PMID: 39672156 BACKGROUND

• 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.

  PMID: 36758194 BACKGROUND

• 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.

  PMID: 36254623 BACKGROUND

• 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.

  PMID: 37568759 BACKGROUND

• 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.

  PMID: 37971743 BACKGROUND

• 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.

  PMID: 39165590 BACKGROUND

• 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.

  PMID: 38398175 BACKGROUND

• 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.

  PMID: 37408671 BACKGROUND

• 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.

  PMID: 37683054 BACKGROUND

• 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.

  PMID: 32426866 BACKGROUND

• 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.

  PMID: 36228645 BACKGROUND

• 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.

  PMID: 12637477 BACKGROUND

MeSH Terms

Conditions

Seminoma

Condition Hierarchy (Ancestors)

Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Ciro Franzese, MD, Radiation Oncologist

CONTACT

+39 0282247454; ciro.franzese@hunimed.eu

Laura Bonavita, Master Degree

CONTACT

+39 0282247026; laura.bonavita@humanitas.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2031
• Last Updated: May 22, 2026

Record last verified: 2026-05