Carbon Ion Boost Followed by Pelvic Proton Radiotherapy for Prostate Cancer With Pelvic Lymph Nodes Metastases: Prospective Phase II Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Biochemical relapse free survival
研究概览
简要总结
The present of clinically pelvic lymph node positive (cN1) represent one of the most important prognostic factors for recurrence and cancer-specific mortality of prostate cancer patients. Approximately 12% of prostate cancer patients present with cN1 disease at the time of diagnosis. Furthermore, with the advent of more sensitive advance diagnostic imaging techniques, such as PSMA PET/CT, the likelihood that pelvic nodes will be found earlier and more frequently.
Unfortunately, The optimal treatment for patients with cN1 still remains unclear. Androgen deprivation therapy (ADT) is the cornerstone of prostate cancer with pelvic lymph node metastasis. Some retrospective and database studies have shown that addition of local radiotherapy (RT) to ADT improve the treatment outcome. The 2022 NCCN guideline recommend RT combined with 2 to 3 years ADT in patients with initially diagnosed cN1 prostate cancer who have a life expectancy greater than 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 85 Years（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;
- •Clinical stage T1-4 N0 M0;
- •Prostatic assessment by multiparametric (mp) MRI;
- •Pelvic lymph node was assessed by PSMA PET/CT and mpMRI;
- •No distant metastasis was proven by PSMA PET/CT;
- •Patients may received neoadjuvant hormonal therapy;
- •45≤ Age ≤85;
- •Adequate performance status (ECOG 0-1);
- •No previous pelvic radiation therapy (RT);
- •No previous prostatectomy;
- •No previous invasive cancer (within 5 years before the prostate cancer diagnosis);
- •Ability to understand character and individual consequences of the clinical trial;
- •Written informed consent;
排除标准
- •No pathologically confirmed adenocarcinoma of the prostate;
- •Distant metastasis (M1);
- •Previous pelvic radiotherapy;
- •Previous prostatectomy;
研究组 & 干预措施
Carbon ion followed by Proton radiotherapy
All patients received whole pelvis and prostate region radiotherapy. The dose to metastatic LN was escalated using simultaneous integrated boost (SIB) technique.
干预措施: proton plus carbon ion radiation (Radiation)
结局指标
主要结局
Biochemical relapse free survival
时间窗: From the start of systemic therapy, a median of 3 years
The prostate specific antigen less than nadir plus 2ng/ml (Phoenix definition)
次要结局
- Acute toxicities(Within 3 months of the start of particle therapy)
- Metastasis free survival(From the start of systemic therapy, a median of 3 years)
- Late toxicities(3 months after the completion of particle therapy)
- Progression free survival(From the start of systemic therapy, a median of 3 years)
- Overall survival(From the start of systemic therapy, a median of 3 years)
研究者
Ping Li
Associate chief physician
Shanghai Proton and Heavy Ion Center