The Herlev Hospital Post Radiation Therapy for Localized Prostate Cancer Database for Sexual Side Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 515
- 主要终点
- Orgasmic dysfunction
研究概览
简要总结
The aim of this study is:
- To investigate which sexual side effects occur after external beam radiation therapy and brachie therapy
- To investigate how many patients are affected
- To investigate if there is a time dependency for the severity of the sexual side effects
- To investigate if there is a dose dependency for the severity of the sexual side effects
- To find predicting and associated factors for the discovered sexual side effects to help identifying patients at risk
详细描述
Aim:
According to the European Association of Urology guidelines radical prostatectomy (RP) and external beam radiation therapy (EBRT) are considered equal treatments with curative intends, for localized prostate cancer [1]. Another type of radiation therapy used to treat localized prostate cancer is brachytherapy (BT). After both RP and EBRT some patients suffer a degree of erectile dysfunction (ED) and urinary incontinence (UI) [2-5]. However, current evidence shows that rates are lower with EBRT [4,5]. Unfortunately, EBRT hold the potential for late-onset toxicity and can, in a small percentage of the patients, lead to secondary genitourinary or gastrointestinal cancers [5]. In a recent study of RP patients at Herlev hospital, the investigators found that many patients, in addition to ED and UI, also suffered from UI during sexual activity, Orgasmic dysfunction, and penile morphological and sensory changes [6]. Only few studies have investigated these side effects in EBRT and BT patients.
The aim for this study is therefore:
- To investigate which sexual side effects occur after EBRT and BT
- To investigate how many patients are affected
- To investigate if there is a time dependency for the severity of the sexual side effects
- To investigate if there is a dose dependency for the severity of the sexual side effects
- To find predicting and associated factors for the discovered sexual side effects to help identifying patients at risk
Background:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients must have received EBRT or BT with curative intent for localized prostate cancer.
- •Only patients who have received EBRT or BT between 3 months and 5 years prior the start of the study will be enrolled.
排除标准
- •Patients who had symptoms corresponding to the abovementioned side effects before EBRT
结局指标
主要结局
Orgasmic dysfunction
时间窗: between 3 months to 5 years after intervention
prevalence rate
Urinary incontinence during sexual activity
时间窗: between 3 months to 5 years after intervention
prevalence rate
penis shortening
时间窗: between 3 months to 5 years after intervention
prevalence rate
anejaculation
时间窗: between 3 months to 5 years after intervention
prevalence rate
sensory changes in the penis
时间窗: between 3 months to 5 years after intervention
prevalence rate
次要结局
- erectile functioning(between 3 months to 5 years after intervention)
- comorbidities(between 3 months to 5 years after intervention)
- gastro intestinal side effects(between 3 months to 5 years after intervention)
- Urinary incontinence(between 3 months to 5 years after intervention)
研究者
Anders Frey
research assistant
Herlev Hospital