Prostate Stereotactic Radiation and Radio-induced Lymphocyte Apoptosis for Predicting Late Toxicities in Prostate Cancer (PROSTERA)

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.

NCT Number	NCT07145437
Lead Sponsor	Clinique Sainte Clotilde
Conditions	Prostate Cancer
Enrollment	220 participants
Start Date	2026-04-01
Primary Completion	2027-11-01 (estimated)
Study Completion	2030-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-18