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

NCT07145437 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

RADIATION

Stereotactic body radiotherapy (SBRT)

SBRT delivered to the prostate with image guidance, respecting dose constraints for organs at risk;

Sponsors & Collaborators

  • Clinique Sainte Clotilde

    lead OTHER

Principal Investigators

  • Mickael DR Begue, Doctor · Clinique Sainte Clotilde

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-11-01
Completion
2030-11-01

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145437 on ClinicalTrials.gov