Personalization of External Beam Radiation Therapy in Localised Tumours (MINIONS)

European Institute of Oncology

Status: Enrolling

Conditions: Breast Adenocarcinoma; Prostate Cancer (Adenocarcinoma)

Treatments: Other: breast patients; Other: prostate patient

Study type: Observational

Funder types: Other

Identifiers

NCT07047495

UID 4631

Details and patient eligibility

About

The study will include the prospective acquisition of optimized MR imaging data of prostate and breast patients treated with radiotherapy (RT).

Within the prospective study, biological specimens from patients undergoing in-room biopsy before RT, will be collected. Histological evaluation and cell culture (and organoid preparation) will be conducted, and samples/organoids will be irradiated with RT for biological validation.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

35 participants in 2 patient groups

Prostate patients

Description:

prostate patients undergoing RT

Treatment:

Other: prostate patient

breast patients

Description:

breast patients undergoing RT

Treatment:

Other: breast patients