Phase I Study Using EUCLIDIAN Robotic Assistance During Prostate Brachytherapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Coverage of the prostate by the prescribed radiation dose at V100
研究概览
简要总结
A robotic brachytherapy device will be used to assist physicians in performing seed implantation to the prostate. EUCLIDIAN is the first robotic system designed to allow automatic placement of radioactive seeds by robot and thus reduce operator dependence. The clinical study is designed to evaluate the dosimetric quality, accuracy and patient self-reported quality of life scores after robotic brachytherapy.
详细描述
EUCLIDIAN (Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing)
The dose-volume histogram parameters of robotic brachytherapy will be compared to historical controls of the study institution. Short-term (<1 yr) health-related quality of life (HRQoL) and changes will be assessed using FACT-P and IPSS self-report questionnaires.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T2b, NX, N0, M
- •Zubrod status 0-
- •Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration
- •No prior pelvic radiation or chemotherapy for any reason; induction hormonal therapy beginning < or = 6 months prior to registration is acceptable.
- •Prostate volume < or = 65 cc prior to registration, or planned use of LHRH agonist therapy for reduction of prostate volume. If LHRH agonist therapy is used to reduce prostate volume, then prostate volume must be < or = 65 cc on the routine pre-implant volume study to be eligible for the study.
- •Gleason score 6, or Gleason Score 7 if both , or = 33% of biopsy cores contain cancer and PSA level is < or = 10 ng/mL.
- •AUA voiding symptoms score < or =
- •Prostate specific antigen (PSA) prior to study entry (and prior to any hormone treatment if given); must be < or = 20 ng/ml.
- •Patients must sign a study-specific consent form prior to registration (Standard of care: only the standard consent form must be signed).
- •Patient must be > or = 40 years old.
排除标准
- •Stage T2c, T3 or T4 disease.
- •Lymph node involvement (pathological N1)
- •Evidence of distant metastases (M1)
- •Gleason score 8-
- •Prostate specific antigen (PSA) prior to study entry > 20 ng/mL.
- •AUA voiding symptoms score >
- •Radical surgery for carcinoma of the prostate.
- •Previous hormonal therapy beginning > 6 months prior to registration
- •Previous or concurrent cancers other than basal or squamous cell skin cancers unless disease- free for > or = 5 years.
- •Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up and/or completion of HRQoL questionnaires (not a condition for ineligibility in Standard of care).
- •Prior TURP
- •Hip prosthesis
结局指标
主要结局
Coverage of the prostate by the prescribed radiation dose at V100
时间窗: Day 0 and Day 30 post-implant
The principal endpoint is the dose-volume histogram (DVH) measured at V100 (percent volume of the target receiving the intended dose). These values will also be compared retrospectively to those in the conventional group. Improved quality will be demonstrated by increased V100 in the protocol patients.
次要结局
- Coverage of the prostate by the prescribed radiation dose at D90(12 months post-treatment)
- Functional Assessment of Cancer Therapy-Prostate (FACT-P)(12 months)
- International Prostate Symptom Score (IPSS)(12 months)