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NCT Number: NCT07601672

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

protontherapy

Radiation

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

Primary outcomes

  1. Treatment toxicities

    Time frame: from enrollment to two years follow up

    Incidence of Grade ≥2 late treatment-related toxicity defined according to CTCAE v6.0 criteria

  2. Progression free survival

    Time frame: 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.

  3. Modeled excess absolute risk (EAR) of secondary malignancies

    Time frame: from treatment to two years follow up

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

Secondary outcomes

  1. Overall survival

    Time frame: from treatment to three years follow up

    Overall survival at 3 years post-treatment defined by survival status of patients at each time point

  2. Quality of life outcomes

    Time frame: 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)

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

    Time frame: 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.

  4. Correlation between miRNA clearance/persistance and outcomes

    Time frame: 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

  5. Quantification of immune cell populations according to cell type

    Time frame: from treatment to two years follow up

    Evaluation of of systemic immune modulation through the analysis of concentration in plasma samples of immune cells

  6. Quality of life outcomes

    Time frame: 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).

  7. Quality of life outcomes

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ciro Franzese, MD, Radiation Oncologist

CONTACT

[email protected]

+39 0282247454

Laura Bonavita, Master Degree

CONTACT

[email protected]

+39 0282247026

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Collaborators

  • Associazione Italiana per la Ricerca sul Cancro

Registry information

Acronym: PRISTINE

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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