Personalized external beam radiation for localised breast and prostate tumours

MINIONS - Patient-specific Microstructural and radIobiological Model for persoNalised External Beam radiatION Therapy in Localised tumourS

This project will test whether using optimized MRI scans plus lab-grown tumor samples can help personalize external beam radiation for adults with localized breast or prostate cancer.

Quick facts

• Study type: Observational
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: European Institute of Oncology (Academic / other)
• Locations: 1 site (Milan, Italy)
• Trial ID: NCT07047495 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (>18) with localized breast (unifocal infiltrating ductal, clinical T1–T2,N0) or localized prostate adenocarcinoma in good general condition (ECOG 0–2), able to undergo MRI and scheduled for active local treatment such as surgery, ablation, or radiotherapy.

Not a fit: Patients with nodal or distant metastasis, multifocal or non‑special breast histology, high‑risk mutation (for breast), contraindications to MRI, significant systemic disease or ongoing anticoagulation, or inability to give informed consent are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help tailor radiation dose and timing to each tumor’s biology, potentially improving tumor control while reducing side effects.

How similar studies have performed: Preclinical and early translational work using organoids and MRI‑guided personalization has shown promising signals, but clinical validation in patient populations remains limited.

Eligibility criteria

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 this trial is running

Milan, Italy

• European Institute of Oncology — Milan, Italy, Italy (Recruiting)

Study contacts

• Principal investigator: Giulia Marvaso — European Institute of Oncology
• Study coordinator: Giulia Marvaso, MD

Conditions Breast Adenocarcinoma; Prostate Cancer