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临床试验/NCT01787630
NCT01787630
Unknown
2 期

Initiating Phase II-III Study to Evaluate the Technique and Effects of Separating the Prostate From the Rectum With Hyaluronic Acid During Radiotherapy

Anders Widmark3 个研究点 分布在 1 个国家目标入组 81 人2010年1月

概览

阶段
2 期
干预措施
未指定
疾病 / 适应症
Prostatic Cancer
发起方
Anders Widmark
入组人数
81
试验地点
3
主要终点
Remaining volume of HA
最后更新
9年前

概览

简要总结

The dominating problem after local radiotherapy of prostate cancer is rectal toxicity. If the rectum could be completely moved out of the treated volume, a substantial decrease of rectal toxicity seems reasonable. In this study we will develop and evaluate a new transrectal injection technique where hyaluronic acid (HA) is injected in the space between the prostate and the rectum prior to external beam radiotherapy to increase the physical distance between prostate and rectum.

注册库
clinicaltrials.gov
开始日期
2010年1月
结束日期
2021年3月
最后更新
9年前
研究类型
Interventional
研究设计
Single Group
性别
Male

研究者

发起方
Anders Widmark
责任方
Sponsor Investigator
主要研究者

Anders Widmark

Professor, MD

Umeå University

入排标准

入选标准

  • Histologically verified prostatic cancer
  • Low or intermediate risk prostatic cancer
  • Lymph node negative
  • Suitable for radiotherapy

排除标准

  • Earlier treatment for prostatic cancer
  • Unable to co-operate or suffering from any other form of disease that would interfere with the planned treatment

结局指标

主要结局

Remaining volume of HA

时间窗: 24 month after end of radiotherapy

Measurement on the remaining volume of HA by MRI

次要结局

  • Quality of life(24 month after end of radiotherapy)

研究点 (3)

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