Personalized external beam radiation for localised breast and prostate tumours

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project will prospectively collect optimized MRI scans from patients with localized breast or prostate adenocarcinoma who are planned for radiotherapy. Before treatment, investigators will obtain in-room biopsies and collect biological specimens for histology and for cell culture and organoid preparation. Samples and organoids will be irradiated ex vivo to measure biological responses and compare them with imaging and treatment plans. The approach aims to link imaging features and laboratory radiation sensitivity to inform more personalized radiation strategies.

Why it matters

Who can join: the full rules

Inclusion criteria for prostate patients:

* Unifocal infiltrating ductal breast carcinoma, non-special histotype
* clinical stage T1-T2,N0
* No contraindications to MRI, or metal joint prostheses from knee to shoulder included, or femoral stent.
* Patients aged \>18 years
* Good general condition (ECOG 0-2)
* Expected active treatment (crioablation or surgery or radiotherapy ).

Exclusion Criteria:

* Exclusion criteria for prostate patients:

  * Nodule involvement and metastasis (cN1 and/or cM1)
  * Concomitant inflammation of the intestine
  * Significant systemic diseases or ongoing oral anticoagulant therapy
  * Non-compliance of dose constraints in the treatment plan
  * Previous invasive cancer, unless the patient has had no disease for at least 3 years
  * Mental disorders that cannot ensure valid informed consent

Exclusion criteria for breast patients:

* Histology other than non-special histotype and non-epithelial tumors (sarcoma, lymphoma)
* Male sex
* High-risk mutation carrier patients
* Bilateral breast cancer
* synchronous distant metastases
* Neoadjuvant therapy
* autoimmune connective tissue diseases
* previous radiotherapy to the chest
* Mental disorders that cannot ensure valid informed consent
* No previous thoracic radiotherapy

Where it's running

• European Institute of Oncology
  Milan, Italy, Italy Recruiting

Study contacts

• Principal investigator: Giulia Marvaso — European Institute of Oncology
• Study coordinator: Giulia Marvaso, MD
• Email: giulia.marvaso@ieo.it
• Phone: +390294372696

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Personal preferences for avoiding gynecomastia (Stage 1)

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• Early postoperative PSA after prostate removal as a predictor of cancer outcomes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.