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临床试验/NCT04278443
NCT04278443Unknown不适用

A Single Site Prospective Descriptive Study on the Effect of Brachytherapy Monotherapy for Prostate Cancer on Male Fertility

East and North Hertfordshire NHS Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年2月24日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
To define effect of prostate brachytherapy on male fertility.

研究概览

简要总结

Although brachytherapy toxicity data on erectile dysfunction, urethral dysfunction and bladder and bowel impact has been collected for a number of years, there is limited information on its effect on male fertility. This study aims to investigate the effect of brachytherapy on fertility

详细描述

Brachytherapy is a commonly employed technique in the treatment of all prostate cancer risk groups. It delivers a high radiation localised to the prostate gland. The effects of this on fertility have not been systematically studied. An increasing number of younger men for whom fertility is an issue are being diagnosed with prostate cancer and may be offered brachytherapy amongst their treatment choices. This study therefore addresses this issue with a systematic evaluation of sperm count and quality before and after both high dose rate and low dose rate brachytherapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •18 years or older
  • •Receiving brachytherapy monotherapy; High or Low dose rate
  • •Ability to ejaculate
  • •Able to provide written informed consent

排除标准

  • •History of infertility or vasectomy
  • •Previous chemotherapy or pelvic radiotherapy
  • •Prior use of androgen deprivation therapy
  • •5 alpha-reductase inhibitors within the last 4 months
  • •Alpha blockers within 7 days of semen collection

结局指标

主要结局

To define effect of prostate brachytherapy on male fertility.

时间窗: 12 months

measure by sequential sperm counts

次要结局

未报告次要终点

研究者

发起方
East and North Hertfordshire NHS Trust
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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