A Feasibility and Safety Study of Focal Interstitial Radiotherapy Using Diffusing Alpha Emitters Radiation Therapy (DaRT) Seeds in Men With Non-metastatic Locally Recurrent Prostate Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of intratumoral DaRT seeds implantation
研究概览
简要总结
This is a multi-center clinical study enrolling up to 10 participants. The purpose of this study is to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of locally recurrent prostate cancer. Secondary objectives are to 1. To evaluate feasibility of interstitial radiotherapy using DaRT seeds.
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging [Timeframe: immediately following the insertion procedure 2. To assess the impact of DaRT seeds on patient reported quality of life.
详细描述
This study is a prospective multicenter, single arm, open label , interventional clinical study to assess the feasibility and safety of intratumoral Alpha DaRT seeds for the treatment of men with non metastatic locally recurrent prostate cancer.
Diffusing Alpha emitters Radiation Therapy (DaRT). Treatment will be delivered through radioactive sources [Ra-224 containing Stainless steel 316LVM tubes- (Alpha DaRT seeds)] inserted into the tumors.
The purpose of this study is to assess the feasibility and safety of intratumoral DaRT seeds implantation for the treatment of locally recurrent prostate cancer. The secondary objectives is 1. To evaluate feasibility of interstitial radiotherapy using DaRT seeds.
Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging [Timeframe: immediately following the insertion procedure 2. To assess the impact of DaRT seeds on patient reported quality of life.
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
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed locally recurrent prostate adenocarcinoma cancer confined to at least 1 hemi-gland with concordant pathology and imaging findings within 6 months prior to consenting
- •Targetable lesion by either PSMA PET-CT according to PERCIST v1.0 or by multiparametric MRI according RECIST v1.1
- •Patient being considered for focal salvage brachytherapy
- •Lesion size ≤ 3 cm in the longest diameter
- •Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds
- •Pre-salvage PSA level (rPSA) below <10 ng/ml
- •Age ≥ 18 years old
- •ECOG Performance Status Scale ≤ 2
- •Subjects' life expectancy is more than 6 months
- •Negative metastatic workup on at least standard imaging (CT CAP and bone scan). Other metastatic screening studies allowed in lieu of standard imaging including multiparametric MRI prostate/whole body, PSMA PET, F18 PET or Axumin PET within 3 months before visit 0
- •Platelet count ≥100,000/mm3
- •Subjects are willing and able to sign an informed consent form.
排除标准
- •N1 or M1 disease
- •Prior TURP or prostate surgery
- •Inability to undergo multiparametric MRI (i.e. permanent implanted device incompatible with MRI)
- •Inability to undergo general or spinal anesthesia
- •Prior androgen deprivation therapy or systemic chemotherapy for prostate cancer within 3 months before visit
- •Previous diagnosis of other malignancy < 3 years of enrollment (excluding non-melanomatous skin cancer)
- •Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT
- •High probability of protocol non-compliance (in opinion of investigator)
- •Subjects not willing to sign an informed consent
- •Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
研究组 & 干预措施
DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
干预措施: Experimental: DaRT seeds (Device)
结局指标
主要结局
Feasibility of intratumoral DaRT seeds implantation
时间窗: immediately following the insertion procedure
To evaluate feasibility of interstitial radiotherapy using DaRT seeds. Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging
次要结局
未报告次要终点