HUmanitas PROtontherapy (HU-PRO) (HU-PRO)

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Proton Therapy

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Marta Scorsetti, MD, Radiation oncologist; Phone Number: +39 0282248524; Email: marta.scorsetti@hunimed.eu
• Study Contact Backup: Name: Davide Franceschini, MD, radiation oncologist; Phone Number: +39 0282247428; Email: davide.franceschini@cancercenter.humanitas.it

Study Locations

• Italy
  • Michigan
    • Rozzano, Michigan, Italy, 20025
      • Recruiting
      • IRCCS Humanitas Research Hospital
      • Contact: Laura Bonavita, master degree; Phone Number: +390282247026; Email: laura.bonavita@humanitas.it
      • Contact: Barbara Alt; Phone Number: +390282248513; Email: barbara.alt@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with indication to proton therapy treatment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
proton therapy; all patients treated with proton therapy according to clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
collecting real world data	To collect real-world data on cancer patients treated with protonherapy, to support research and to provide evidence of the role of protontherapy in a multidisciplinary approach.	from enrollment to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monitor Treatment Adherence and Compliance	Evaluate factors influencing patient adherence to treatment schedules and follow up care	from enrollment to 10 years
toxicities profiles	Asses acute and late onset side effects and compare toxicity rates with conventional radiotherapy (toxicity classification by CTCAE)	from enrollment to 10 years
identify prognostic biomarkers	Investigate biological and clinical factors that influence treatment response and survival (blood samples and saliva samples for Head&Neck patients)	from enrollment to 10 years
Optimize treatment plannig	Asses different proton therapy techniques and procedures to refine clinical practice (Radiotherapy plans comparison)	from enrollment to 10 years
Secondary Cancer Risk	Monitoring long term cancer incidence in patients treated with proton therapy, especially in young patients (clinical data comparison - appearance of disease after treatment)	from enrollment to 10 years
Asses Outcomes in Rare or Radioresistant Tumors	Collect data on tumor types with limited evidence to determine optimal indications for proton therapy (clinical data comparison)	from enrollment to 10 years
Analyze Quality of Life Outcomes	Measure patient reported outcomes (PROs) to understand the impact of proton therapy on daily life and well being (QLQ-C30 and different questionnaries according to pathology site)	from enrollment to 10 years

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: cancer; registry; re-irradiation; proton therapy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PRO/OSS - 001/2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No