PRISTINE Trial: PRoton Beam Therapy In Seminoma - Toxicity INvestigation and Evaluation of Outcome (PRISTINE)
15. mai 2026 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ciro Franzese, MD, Radiation Oncologist
- Telefonnummer: +39 0282247454
- E-post: ciro.franzese@hunimed.eu
Studer Kontakt Backup
- Navn: Laura Bonavita, Master degree
- Telefonnummer: +39 0282247026
- E-post: laura.bonavita@humanitas.it
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Treatment toxicities
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. mai 2026
Primær fullføring (Antatt)
1. mai 2031
Studiet fullført (Antatt)
1. mai 2031
Datoer for studieregistrering
Først innsendt
24. april 2026
Først innsendt som oppfylte QC-kriteriene
15. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PRO - 2026 - 001
- IG 2025 ID 32742 (Annet stipend/finansieringsnummer: AIRC)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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