Radioablation +/- Hormonotherapy for Prostate Cancer Oligorecurrences (RADIOSA Trial): Potential of Imaging and Biology
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
A randomized phase II clinical trial (RADIOSA trial: Radioablation with or without Androgen DeprIvation therapy in metachronous prostate cancer OligometaStAsis).
The aim is to compare time to progression between the two study arms: SBRT only or SBRT and hormonotherapy (ADT). The primary objective is to compare the progression-free survival (PFS) defined as the absence of new metastatic lesions (local, regional or distant) between the two arms. The secondary endpoints include the comparison of overall survival (OS), biochemical progression-free survival (BPFS), ADT-free survival, local control, treatment-induced acute and late toxicity, time to castration-resistant disease and QoL between the two arms; the development of a dedicated biobanking (collection of plasma and serum) for further biological investigation of predictive/diagnostic factors for personalized treatment; the preliminary evaluation of prognostic biomarkers; the correlation between imaging-derived parameters and treatment outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically proven initial diagnosis of adenocarcinoma of the prostate;
- •Biochemical relapse of PCa following radical local prostate treatment (radical prostatectomy, primary radiotherapy or radical prostatectomy +/- prostate bed adjuvant/salvage radiotherapy) +/- ADT according to the European Association of Urology (EAU) guidelines 2016 [18] or after any salvage therapy if biochemical progression is diagnosed in the context of castration sensitive PCa;
- •Nodal relapse in the pelvis, extra-regional nodal relapse (M1a), bone metastases (M1b) on Ch-PET/CT or WBMRI with a maximum of 3 lesions;
- •Serum testosterone level >50 ng/dl at the time of randomization (castration sensitive PCa)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •Age ≥18 years;
- •Written informed consent signed
- •Exclusion criteria
- •Serious concomitant comorbidities or contraindication to SBRT and/or ADT;
- •Previous invasive cancer (within 3 years before the prostate cancer diagnosis) apart from non-melanoma skin malignancies;
- •No ability to complete questionnaires about QoL;
- •Presence of mental diseases that cannot ensure valid informed consent;
排除标准
- 未提供
研究组 & 干预措施
Stereotactic body Radiotherapy (SBRT) only
ARM 1: salvage SBRT for lymph nodes and/or bone metastases. All the radiologically documented lesions will be treated simultaneously.
干预措施: SBRT (Radiation)
Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT)
ARM 2: salvage SBRT (as described for ARM 1) + 6-month ADT (luteinizing hormone-releasing hormone (LHRH) agonist or antagonist). ADT should start within one week before the start of SBRT.
干预措施: Androgen deprivation therapy (ADT) (Drug)
Stereotactic body Radiotherapy (SBRT) and hormonotherapy (ADT)
ARM 2: salvage SBRT (as described for ARM 1) + 6-month ADT (luteinizing hormone-releasing hormone (LHRH) agonist or antagonist). ADT should start within one week before the start of SBRT.
干预措施: SBRT (Radiation)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up 3 months from the end of the treatment up to radiological progression within 3 years
Defined as the absence of new metastatic lesions (local, regional or distant) between the two arms.
次要结局
- Biochemical progression-free survival (BPFS)(up 3 months from the end of the treatment up to 3 years)
- Numbers of patients who experienced acute and late toxicity(Up to 1 months after treatment completion and then up to 3 years)
- Overall survival (OS)(Up the end of SBRT until death for cancer or other causes up to 3 years)