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Prostate Stereotactic Radiation and Radio-induced Lymphocyte Apoptosis for Predicting Late Toxicities in Prostate Cancer (PROSTERA)
Sponsor: Clinique Sainte Clotilde
Summary
This monocentric interventional study investigates whether the Radio-induced Lymphocyte Apoptosis (RILA) assay can predict the occurrence of late radiation-induced toxicities in patients with localized prostate cancer treated with stereotactic body radiotherapy (SBRT). Eligible patients will undergo a peripheral blood sample collection for the RILA test prior to SBRT. Toxicities will be assessed using CTCAE v5.0 criteria, and quality of life will be evaluated with EORTC QLQ-PR25, QLQ-C30, and IPSS questionnaires over a 60-month follow-up. The results aim to optimize patient selection for SBRT and reduce the risk of severe late side effects.
Official title: Evaluation of the Prognostic Value of Radio-induced Lymphocyte Apoptosis for Predicting Late Radiation-induced Toxicities After Stereotactic Body Radiotherapy in Patients With Localized Prostate Cancer
Key Details
Gender
MALE
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2026-04-01
Completion Date
2030-11-01
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
Radio-induced Lymphocyte Apoptosis (RILA) Assay
peripheral blood sample processed via the RILA assay to quantify apoptotic CD8+/CD4+ T cells following ex vivo irradiation.
Stereotactic body radiotherapy (SBRT)
SBRT delivered to the prostate with image guidance, respecting dose constraints for organs at risk;