Comparative Effectiveness of New Treatment Modalities for Localized Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 480
- 主要终点
- Impact of treatments' side effects on patients' quality of life measured in terms of change in the score of the Expanded Prostate Cancer Index Composite (EPIC) from baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment.
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of four of the nowadays most established primary treatments for patients with clinically localized prostate cancer (active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy) at short-, mid- and long-term follow-up. The primary aim is assessing the impact of treatments' side effects on patient's quality of life. As secondary objectives, biochemical disease-free survival, overall survival, and prostate cancer-specific survival will also be assessed.
详细描述
Primary Objective:
To compare the impact of active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy in patients with localized prostate cancer, in Patient-Reported Outcome Measures, considering side effects and physical and mental health at short-, mid- and long-term follow-up.
Secondary Objectives:
To assess biochemical disease-free survival by treatment and risk group, at mid- and long-term follow-up.
To assess overall survival by treatment and risk group, at mid- and long-term follow-up.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age between 50 and 75 years.
- •Clinical stage T1 or T2, N0/Nx and M0/Mx.
- •Gleason ≤6 or 7 (if 3+4 with T1c).
- •Prostate-Specific Antigen (PSA) ≤ 10 .
- •To be treated with active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy or real-time brachytherapy
排除标准
- •Body mass index >
- •Neoadjuvant hormonal treatment.
- •Previous pelvic treatments.
- •Presence of serious comorbidities.
结局指标
主要结局
Impact of treatments' side effects on patients' quality of life measured in terms of change in the score of the Expanded Prostate Cancer Index Composite (EPIC) from baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment.
时间窗: Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment
The Expanded Prostate Cancer Index Composite-26 (EPIC-26) is a prostate cancer-specific questionnaire that measures urinary, sexual, bowel, and hormonal domains, ranging from 0 to 100. Response options for each EPIC item are on a 4-, 5-, or 6-level Likert scale. Items are grouped in summary scores for sexual, bowel, and hormonal domains, and in 2 scores for the urinary domain (incontinence and irritative/obstructive symptoms), which are transformed linearly to a scale from 0 to 100, where higher scores indicate better outcomes.
次要结局
- Biochemical disease-free survival(5, 7, 10, 15, and 20 years after treatment)
- Disease-specific Quality-Adjusted Life Years measured with the Patient-Oriented Prostate Utility Scale(Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment)
- Quality-Adjusted Life Years measured with the EuroQol-5 Dimensions(Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment)
- Prostate cancer-specific survival(5, 7, 10, 15, and 20 years after treatment)
- Overall survival(5, 7, 10, 15, and 20 years after treatment)
- Perceived general health measured with the 36-item Short-Form Health Survey version 2 (SF-36v2)(Baseline to 1, 3, 6, 12, 24, 60, 84, 120, 180, and 240 months after treatment)
研究者
Montserrat Ferrer
Medical Doctor, PhD
Fundacion IMIM