Prostate-cancer Treatment Using Stereotactic Radiotherapy for Oligometastases Ablation in Hormone-sensitive Patients - a GETUG-AFU Phase III Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 550
- 试验地点
- 35
- 主要终点
- Castration-resistant prostate cancer free survival
研究概览
简要总结
INDICATION: Oligometastatic hormone-sensitive prostate cancer patients. METHODOLOGY: Open label, double arm, randomized 1:1, multicenter phase III study.
PRIMARY OBJECTIVE: To assess the efficacy of ablative radiotherapy (SBRT applied to all oligometastases) administered to all gross tumor sites (metastases and prostate if applicable), in oligometastatic hormone-sensitive prostate cancer patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Standard of care + Stereotactic Body Radiotherapy to oligometastases
干预措施: Stereotactic Body Radiotherapy (SBRT) + Standard of care (Radiation)
Arm B
Standard of care
干预措施: Standard of care (Drug)
结局指标
主要结局
Castration-resistant prostate cancer free survival
时间窗: From randomization to castration resistance or death from any cause, up to 1 year
Castration-resistant prostate cancer free survival, defined as the time from randomization to castration resistance or death from any cause. Castration resistance is defined as either biochemical progression or radiological progression, with serum testosterone being at a castrated level (\<50 ng/dL or \<1.7 nmol/L).
次要结局
- Overall survival(From randomization to death from any cause, up to 5 years)
- Prostate cancer specific survival(From randomization to death from prostate cancer, up to 5 years)
- Time to castration resistance(Time from randomization to castration resistance, up to 5 years)
- Time to next symptomatic skeletal event(Time from randomization to the first symptomatic skeletal event, up to 5 years)
- Time to next symptomatic skeletal event at the treated metastatic bone sites(Time from randomization to the first symptomatic skeletal event, 5 years)
- Time to use of intermittent hormonal therapy(Time from randomization to the use of intermittent androgen deprivation therapy, up to 5 years)
- Duration of intermittent hormonal therapy(From the end of continuous therapy to the end of intermittent therapy, up to 5 years)
- Time to secondary treatments (local or systemic)(From randomization to initiation of secondary treatment, up to 5 years)
- Acute and late toxicity of stereotactic radiotherapy of oligometastases: Adverse events(Throughout study completion, up to 5 years)
- Severity of pain during treatment(At baseline before radiotherapy, week 6, and at every follow-up (every three months for the first three years then every 6 months for the last two years after randomization), up to 5 years)
- The 3-level version of EQ-5D (EQ-5D-3L) questionnaire(At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and at castration resistance (up to 5 years))
- Expanded Prostate Cancer Index Composite (EPIC) short form(At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, and at castration resistance (up to 5 years))
- Cost-effectiveness analysis of the proposed therapeutic strategy(At baseline, week 6, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years, castration resistance (up to 5 years))