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临床试验/NCT04282876
NCT04282876招募中不适用

Influence of Hormone Treatment in Radiation Therapy for Bladder Cancer

Aarhus University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年2月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Bladder fibrosis

研究概览

简要总结

Bladder cancer is often treated with cystectomy or radiation therapy. Following radiation therapy patients will often have severe side effects from the treatment. Studies have suggested that simultanously treatment with androgen deprivation therapy during radiation therapy may be able to proctect stemcells in the bladder, thus improving tissue recovering post-radiation, which would result in improved bladder compliance following the treatment and ultimately result in fewer side effects and overall improved patient quality of life.

详细描述

Bladder cancer (BC) is one of the most frequent cancers in the world and more common in men than female. Gender-related factors may be involved in the pathogenesis of BC.

Studies have suggested that androgen-receptors may be present in the bladder and potentially involved in BC aetiology, thus making BC susceptible for androgen deprivation therapy (ADT).

Currently treatment for BC includes surgery or radiation therapy. ADT include Degarelix, which besides decreasing testosterone, has been shown to reduce the occurrence of BC in rats and promote stem cell recovery following radiation therapy.

Hypothesis ADT will lower the incidence of BC, and the prognosis of BC will vary depending on the type of ADT used. Furthermore Degarelix administered during radiation therapy for BC will reduce the degree of fibrosis in the bladder thus decreasing adverse side effects.

Methods A cohort of patients treated with ADT for PC will be compared to two cohorts of age-matched men with and without PC both without ADT. The incidence of BC will be recorded for every group. Furthermore the cohort of patients with PC and ADT will be divided into subgroups, depending of the type of ADT they have received and the degree of deprivation. They will be compared in terms of incidence and prognosis of BC.

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

入选标准

  • T2-T4 bladder cancer
  • radiation therapy
  • able to fill out questionnaires
  • signed informed consent

排除标准

  • KAD prior to TUR-B
  • dementia or other cognitive impairment
  • metastatic disease

研究组 & 干预措施

Degarelix

Patients undergoing radiation therapy for bladder cancer while also being treated with Degarelix (androgen deprivation therapy)

干预措施: Degarelix (Drug)

结局指标

主要结局

Bladder fibrosis

时间窗: 3 months after radiation

Fibrosis of the bladder determined by bladder biopsy estimated by number of fibrotic fibers on IHC staining

次要结局

未报告次要终点

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jørgen Bjerggaard Jensen

Professor

Aarhus University Hospital

研究点 (1)

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