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临床试验/NCT02290366
NCT02290366撤回不适用

Prospective Evaluation of Focal Brachytherapy Using Cesium-131 For Patients With Low Risk Prostate Cancer

Ronald M. Benoit, MD2 个研究点 分布在 1 个国家开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
biochemical disease free survival

研究概览

简要总结

The standard options for men with very low risk prostate cancer include active surveillance and the standard treatment options for low risk disease, i.e. radical prostatectomy, external beam radiotherapy, and whole gland prostate brachytherapy. The present study seeks to evaluate focal brachytherapy using the isotope Cesium 131 to treat patients with low risk prostate cancer. The goals of the study are to determine the biochemical disease free survival at five years in these patients, as well as to determine the acute and late urinary, bowel, and sexual toxicity associated with focal prostate brachytherapy using Cesium 131. Patients eligible for the study will be men with histologically confirmed adenocarcinoma of the prostate with clinical stage T1c-T2aN0M0, Gleason score ≤3+3=6, prostate specific antigen(PSA) <10 ng/ml or a PSA density ≤ 0.15 ng/cc, and ≤ 2 cores positive out of a minimum of 12 cores sampled. Additionally, patients must have a single, dominant index lesion on MRI. The study is a phase II study. Patients will be followed prospectively. Dosimetry will be evaluated post-procedure, and PSAs will be obtained every three months in year one and every six months from year two through year five. Urinary, bowel, and sexual morbidity will be assessed by patient survey prior to treatment , two weeks, after treatment, at three month intervals in year one and at six month intervals in years two through five.

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

性别
Male
接受健康志愿者

入选标准

  • Histologically confirmed adenocarcinoma of the prostate
  • Clinical stage T1c-T2aN0M0
  • Gleason score <= 3+3=6
  • prostate specific antigen (PSA) <10 ng/ml
  • <= 2 cores positive out of a minimum of 12 cores sampled

排除标准

  • 未提供

结局指标

主要结局

biochemical disease free survival

时间窗: five years

次要结局

未报告次要终点

研究者

发起方
Ronald M. Benoit, MD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ronald M. Benoit, MD

Associate Professor

University of Pittsburgh

研究点 (2)

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