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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- Occurrence of one or more late radiation-induced complications
研究概览
简要总结
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.
详细描述
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 radiation-induced toxicities in patients with localized prostate cancer treated with stereotactic body radiotherapy (SBRT).
The primary objective is to determine whether pre-treatment RILA (percentage of apoptotic T-lymphocytes measured ex-vivo after controlled irradiation) is predictive of clinically meaningful late toxicities graded ≥2 according to CTCAE v5.0 within 24 months after SBRT. Secondary objectives include PSA kinetics, patient-reported outcomes (EORTC QLQ-PR25, QLQ-C30 and IPSS), dosimetric correlations, and estimation of diagnostic performance metrics (AUC, sensitivity, specificity) of the RILA assay.
A single peripheral blood sample (2 mL) is collected at the time of CT simulation (inclusion visit). Samples are transported to the designated laboratory (LIRS/RunResearch) and processed according to the RILA SOP: cells are placed in culture (RPMI 1640 + 20% FBS, dilution 1:10) within 4 hours of collection, incubated 16-24 hours, then irradiated ex-vivo (8 Gy; conformational irradiation using institutional accelerator) and incubated for an additional 48 hours. After post-irradiation incubation cells are stained for CD4/CD8 and propidium iodide and analysed by flow cytometry (FACS) on 10,000 events in triplicate to derive the percentage of apoptotic CD4+ and CD8+ T-cells. All assay timings and plate/aliquot identifiers are recorded in laboratory logs. The collected sample is entirely consumed for the assay (no sample retention).
Eligible participants are adult males with localized prostate adenocarcinoma meeting the protocol inclusion criteria (e.g. clinical stage T1-T2, Gleason score 6-7, PSA <15 ng/mL as per protocol), able to provide written informed consent and compliant with follow-up procedures. Key exclusions include prior pelvic radiotherapy, metastatic disease, inability to consent, and other criteria listed in the protocol. Enrollment will be consecutive to limit selection bias.
All participants receive SBRT delivered according to institutional conformational technique (protocol-specified dose constraints and organ-at-risk delineation per RTOG recommendations; typical stereotactic schedule described in the protocol). Imaging data (centering CT and any low-dose CT), treatment plans and dose-volume histograms (DVH) will be collected and stored in the electronic CRF for dose-toxicity correlation analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Occurrence of one or more late radiation-induced complications
时间窗: 24 months post-stereotactic radiotherapy
Number of participants presenting one or more late radiation-induced complications, assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
次要结局
- Mortality rate of T-CD8+/-CD4+ lymphocytes(After in vitro culture and irradiation at 8 Gy)
- Clinical and biological variables of patients(At baseline and during follow-up (up to 60 months post-radiotherapy))
- Quality of life - EORTC QLQ-PR25(Baseline, 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months post-radiotherapy)
- Quality of life - EORTC QLQ-C30(Baseline, 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months post-radiotherapy)
- Urinary symptoms - International Prostate Symptom Score (IPSS)(Baseline, 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months post-radiotherapy)
- Treatment tolerance - Number of participants with adverse events(Baseline, 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months post-radiotherapy)