HUmanitas PROtontherapy (HU-PRO)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer, Proton Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Proton therapy is a cancer treatment, similar to the more commonly used radiation therapy. It uses radiation to destroy cancer cells and helps control the disease in the treated area. However, when proton therapy is compared with standard radiation therapy, many studies show fewer side effects and better disease control. This is due to the unique physical properties of the particles used in proton therapy. At present, in Italy, this innovative treatment is available only for selected diseases, as defined by national guidelines. For this reason, it is very important to collect as much data as possible to support the further development of proton therapy and to improve treatment safety and effectiveness.
Primary outcome measures
- collecting real world data [Time frame: from enrollment to 10 years]
Secondary outcome measures (7)
- toxicities profiles [Time frame: from enrollment to 10 years]
- identify prognostic biomarkers [Time frame: from enrollment to 10 years]
- Optimize treatment plannig [Time frame: from enrollment to 10 years]
- Secondary Cancer Risk [Time frame: from enrollment to 10 years]
- Asses Outcomes in Rare or Radioresistant Tumors [Time frame: from enrollment to 10 years]
- Monitor Treatment Adherence and Compliance [Time frame: from enrollment to 10 years]
- Analyze Quality of Life Outcomes [Time frame: from enrollment to 10 years]
Eligibility criteria
Inclusion criteria
- Solid tumors candidate to proton therapy, in particular, according to Italian regolamentations
- Written informed consent for HU-PRO according to applicable legal and ethical requirements
- Indication for proton therapy
- ≥ 18 years old
- ECOG PS (performance status scale) 0-2
Exclusion criteria
- Age < 18 years old
- ECOG (performance status scale) >3
- Life expectancy < 3 months
- Inability to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- IRCCS Humanitas Research Hospital — Rozzano
Identifiers
NCT: NCT07317245 · PRO/OSS - 001/2026