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

May 15, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protontherapy Treatment
patient will be treated with protontherapy instead of radiotherapy
Radiation: protontherapy
patients will be treated with protontherapy instead of radiotherapy with photon as standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from enrollment to two years follow up
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.
from enrollment to 12 months from treatment
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)
from treatment to two years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from treatment to three years follow up
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)
from treatment to two years follow up
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.
from treatment to two years follow up
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
from treatment to two years follow up
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
from treatment to two years follow up
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).
from treatment to two years follow up
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).
From treatment to two years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Collaborators

AIRC (Italian Association for Cancer Research)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

April 24, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO - 2026 - 001
  • IG 2025 ID 32742 (Other Grant/Funding Number: AIRC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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