Functional Image-Guided Carbon Ion Irradiation With Simultaneous Integrated Boost for Prostate Cancer: a Phase II Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Acute toxicities
研究概览
简要总结
This is a phase II randomized controlled clinical trial to assess the toxicities and clinical efficacy of prostate specific membrane antigen (PSMA) positron emission tomography / computed tomography (PET/CT) and multi- parameter Magnetic Resonance Imaging (MRI) guided simultaneous integrated boost for prostate cancer.
详细描述
Local recurrences of prostate cancer following radiotherapy often originate from the primary tumor site. Therefore,focal boost to the primary gross tumor has been proposed to increase biochemical disease-free survival (bDFS) without increasing toxicity.
The higher relative biological effectiveness (RBE) and greater cytocidal effect on the intrinsic radiation resistant cancer cells offer carbon ion radiotherapy (CIRT) advantages over conventional radiotherapy. In this study, carbon ion were used to treat localized prostate cancer and simultaneous integrated boost to the gross tumor in the prostate specific membrane antigen (PSMA) PET/CT and multi- parameter MRI.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed adenocarcinoma of prostate
- •Stage cT1-3N0M0 localized prostate cancer
- •performed PSMA PET/CT and mpMRI before treatment
- •No lymph nodes or distant metastasis
- •Age ≥ 45 and < 85 years of age
- •Karnofsky Performance Score ≥70
- •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
- •Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial
排除标准
- •No pathologically confirmed adenocarcinoma of the prostate
- •Pelvic lymph node metastasis (N1)
- •Distant metastasis (M1)
- •Previous pelvic radiotherapy
- •Previous prostatectomy
结局指标
主要结局
Acute toxicities
时间窗: Within 3 months of the start of CIRT
Treatment related acute toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
次要结局
- Late toxicities(3 months after the completion of CIRT)
- Biochemical failure free survival(From the complation of CIRT,a median of 5 years)
- Progression free survival(From the complation of CIRT,a median of 5 years)
- Overall survival(From the diagnosis of prostate cancer,a median of 5 years)
研究者
Ping Li
Principal Investigator
Shanghai Proton and Heavy Ion Center