Clinical trial · Interventional
Prostate Stereotactic Radiation and Radio-induced Lymphocyte Apoptosis for Predicting Late Toxicities in Prostate Cancer (PROSTERA)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radio-induced Lymphocyte Apoptosis (RILA) Assay | Diagnostic Test | — | UNRESOLVED |
| Stereotactic body radiotherapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: SBRT + RILA assay (single-arm)
- description
- All participants assigned to this single experimental arm will receive stereotactic body radiotherapy (SBRT) to the prostate delivered according to the PROSTERA protocol with predefined dose prescription and organ-at-risk constraints. A single peripheral blood sample (2 mL, lithium-heparin) will be collected at the time of CT simulation for the Radio-induced Lymphocyte Apoptosis (RILA) assay. Samples are transported and processed at the designated laboratory (LIRS) and handled per the RILA SOP: processing within 4 hours of collection, incubation 16-24 hours, ex-vivo irradiation (8 Gy), further incubation 48 hours, staining for CD4/CD8 and propidium iodide, and flow cytometry analysis (10,000 events, measured in triplicate) to quantify apoptotic T-lymphocytes. RILA results will be used for correlative and prognostic analyses versus late genitourinary and gastrointestinal toxicities (CTCAE v5.0), PSA kinetics and patient-reported outcomes (EORTC QLQ-PR25, QLQ-C30, IPSS).
- interventionNames
- Diagnostic Test: Radio-induced Lymphocyte Apoptosis (RILA) Assay
- Radiation: Stereotactic body radiotherapy (SBRT)
Primary outcomes (1)
- measure
- Occurrence of one or more late radiation-induced complications
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
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