Efficacy of Advanced Radiotherapy (ART) in Prostate Cancer Patients With Early Stage, Advanced, Metastatic and Relapsed Disease (PROST-ART)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Local Relapse Free Survival
研究概览
简要总结
This is a retrospective monoinstitutional study which analyses the results of advanced radiotherapy (IGRT, IMRT, SBRT, and PET-guided) performed for radical, adjuvant, or salvage purposes in patients with low, intermediate, high, and very high-risk prostate cancer, or with biochemical, lymph node, or oligometastatic recurrence treated between 2004 and 2024.
Approved by Ethics Committee of IRCCS San Raffaele Hospital Approval Number: 187/INT/2021, 03/02/2022
Amendment approved by Ethics Committee 1, Lombardy Region Approval number CET Em. 194-2024, 22/05/2024
详细描述
This is a single-center, retrospective study (PROST-ART) that has as its primary objective the evaluation of the efficacy of radiotherapy treatments performed in patients with early-stage, advanced, metastatic prostate disease, with biochemical relapses after surgery, with local relapses after radiotherapy, or oligometastatic/oligoprogressive disease. The aim of the study is to measure the biochemical relapse-free survival (bRFS), local and regional relapse (LR, regional relapse, RR), distant metastases-free survival (DMS), clinical relapse (DFS), disease-free survival (PCSS), and overall survival (OS) from both disease diagnosis and the end of radiotherapy until the last useful follow-up, or until the patient's death. In addition, the acute and late toxicity of treatments will be assessed from the start of treatment until the last follow-up/death of the patient and the period without other oncological treatments, from the end of treatment until the start of another oncological treatment/last follow-up.
At least 200 patients treated in the last 5 years, some receiving stereotactic radiotherapy to the prostate, or prostate and seminal vesicles, and the others pelvic lymph node and prostate irradiation, who are still alive and contactable, and agree to participate, will be included in a survey on quality of life (QoL). These patients, after signing an informed consent for the collection of new information, will receive an EORTC QLQ-PR25 quality of life questionnaire, in order to quantify the impact of toxicity. In addition, the radiomic characteristics of the computed tomography/ PET-CT performed for treatment planning along with evaluation of the results will be extracted to identify related predictive factors.
The QoL study is configured as retrospective as the questionnaire will only be an expression, from the patient's point of view, of the toxicity of the previous treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients, > 18 years old, treated with IGRT, IMRT, SBRT
排除标准
- •other tumors
- •> 95 years old
结局指标
主要结局
Local Relapse Free Survival
时间窗: From the date of radiotherapy end until the date of local progression or date of death from any cause, whichever came first, assessed up to 120 months
Local control of the disease (at the treated site)
Disease Free Survival
时间窗: From the date of radiotherapy end until the date of first documented clinical progression or date of death from any cause, whichever came first, assessed up to 120 months
Absence of disease progression during the follow-up
Regional Relapse Free Survival
时间窗: From the date of radiotherapy end until the date of regional progression or date of death from any cause, whichever came first, assessed up to 120 months
Regional control of the disease (at the regional lymph node chain)
Distant Metastasis Free Survival
时间窗: From the date of radiotherapy end until the date of distant progression or date of death from any cause, whichever came first, assessed up to 120 months
Distant Metastasis developed after the treatment
Overall Survival
时间窗: From the date of radiotherapy end until the date of death from any cause, assessed up to 120 months
Survival from all causes
Cancer Specific Survival
时间窗: From the date of radiotherapy end until the date of death from disease progression, assessed up to 120 months
Cancer Survival
Biochemical relapse free survival
时间窗: From the date of radiotherapy end until the date of biochemical progression or date of death from any cause, whichever came first, assessed up to 120 months
Biochemical relapse after the treatment
次要结局
- Late toxicity(From three months after the start of radiotherapy until the end of follow-up or death, assessed up to 120 months)
- Acute Toxicity(Up to three months from the start of radiotherapy)
研究者
Nadia Di Muzio
Professor
IRCCS San Raffaele