Status:
NOT_YET_RECRUITING
Prostate Stereotactic Radiation and Radio-induced Lymphocyte Apoptosis for Predicting Late Toxicities in Prostate Cancer (PROSTERA)
Lead Sponsor:
Clinique Sainte Clotilde
Conditions:
Prostate Cancer
Eligibility:
MALE
60+ years
Phase:
NA
Brief 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 localize...
Detailed Description
PROSTERA is a prospective, single-arm, monocentric interventional study (RIPH-2) designed to evaluate the prognostic performance of the Radio-induced Lymphocyte Apoptosis (RILA) assay to predict late ...
Eligibility Criteria
Inclusion
- Male, aged 60 years or older, presenting with localized prostate cancer of low or intermediate risk (T1-T2 stage, Gleason score 6-7, and PSA \<15 ng/mL) without metastatic disease, and for whom radiotherapy is indicated.
- Patient affiliated with, or beneficiary of, the French national health insurance system.
- French-speaking patient.
- Patient who has been informed about the study and has provided written informed consent.
Exclusion
- Patient unable to read, write, or understand French.
- Vulnerable patient as defined in Article L1121-6 of the French Public Health Code.
- Adult under legal guardianship, curatorship, or judicial protection.
- Patient unable to personally provide informed consent as per Article L1121-8 of the French Public Health Code, or adult protected by law.
- Patient already enrolled in an interventional study that could influence the outcomes of the present study.
- Patient with a history of prostate and/or digestive surgery.
- Refusal to sign the written informed consent at inclusion.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2030
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT07145437
Start Date
October 1 2025
End Date
November 1 2030
Last Update
September 10 2025
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