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

ConditionSeminoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorIstituto Clinico Humanitas

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Male gender

ECOG Performance status 0 - 1

Histologically confirmed diagnosis of testicular seminoma

Disqualifiers

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

Trial design

Treatments tested in this trial

  • protontherapy

Treatment groups

20 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Istituto Clinico Humanitas

Lead sponsor

AIRC (Italian Association for Cancer Research)

Collaborator