Health-Related Quality of Life in Prostate Cancer Patients Treated With Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- EPIC questionnaire score on bowel domain
研究概览
简要总结
The study primarily aims at evaluating health-related quality of life after radiotherapy for prostate cancer, using modern hypofractionated radiotherapy schedules. Study design is a prospective observational cohort study. All patients give written informed consent and fill out online validated questionnaires before, during, and after radiotherapy (yearly) up to 5 years post-treatment.
详细描述
Rationale: Patient-Reported Outcomes (PROs), such as health-related quality of life (HRQL), have achieved an important role in the evaluation of benefits and harms after cancer treatment, including radiotherapy for prostate cancer (PCa). In the past year, clinical radiotherapy protocols at the Erasmus MC have been changed for external beam radiotherapy (EBRT) as well as for brachytherapy (BT). In order to evaluate the current, changed, clinical practice, we will conduct a prospective cohort study, with the main purpose to assess HRQL for the current treatment options at the Erasmus MC.
Objective: To establish HRQL (start treatment - 5 years after treatment) in a prospective cohort of ≈600 patients with localized PCa treated with radiotherapy within in the period ≈ 1/3/2019 - 1/12/2023.
Main objective: to establish changes in HRQL levels (with respect to baseline) up to 5 year post-treatment, within each radiotherapy modality for prostate cancer patients, i.e. EBRT 60 Gy in 20 fractions, EBRT 42.7 Gy in 7 fractions, CyberKnife (stereotactic EBRT) 38 Gy in 4 fractions, BT 27 Gy in 2 fractions, postoperative EBRT (PORT) 72 Gy in 36 fractions, EBRT for LN+: 70 Gy (prostate)/52 Gy (lymph nodes) in 28 fractions.
Study design: Prospective observational cohort study. Study population: Patients with prostate cancer T1c-T4 referred for radiotherapy at the Erasmus MC as a primary treatment with curative intent or as first line adjuvant treatment after a prostatectomy.
Intervention: All interventions are according to applicable standard clinical procedures & protocols for localized prostate cancer of the Radiotherapy department.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Clinically T1c-T4, N0 (or N+ in case of EBRT-LN+), M0 prostate cancer patient referred for radiotherapy.
- •Willing and capable to fill out Dutch questionnaires on health-related items at a computer (online questionnaires).
- •Signed written Informed Consent.
排除标准
- •Previously radiation treatment in the pelvic region, for any reason.
- •Diagnosed with other tumor in the past 12 months or known with tumor progression of another tumor.
- •Postoperative radiotherapy with dose levels < 72 Gy.
结局指标
主要结局
EPIC questionnaire score on bowel domain
时间窗: Year 1 - Year 4
Expanded Prostate Cancer Index Composite (EPIC) Bowel Domain score: a 0 to 100 scale with higher scores representing better HRQOL.
Sexual functioning score on IIEF-5 questionnaire
时间窗: Year 1- Year 4
Sexual functioning score on International Index of Erectile Function (IIEF-5) questionnaire: 1 to 25 scale, higher scores imply better function
EPIC questionnaire score on urinary domain
时间窗: Year 1 - Year 4
Expanded Prostate Cancer Index Composite (EPIC) Urinary Domain score: a 0 to 100 scale with higher scores representing better HRQOL.
次要结局
- Late erectile dysfunction(Year 1- Year 4)
- Acute rectal bleeding, on symptom checklist (patient-reported)(During radiotherapy - 3 months after radiotherapy)
- Late moderate to severe urinary frequency during the night(Year 1 - Year 4)
- Late moderate to severe incontinence for stools(Year 1 - Year 4)
- Late frequent bowel movements(Year 1 - Year 4)
- Acute mucous discharge, on symptom checklist (patient-reported)(During radiotherapy - 3 months after radiotherapy)
- Late moderate to severe urinary incontinence(Year 1 - Year 4)
研究者
Wilma Heemsbergen
Clinical Epidemiologist, Project Leader, PhD
Erasmus Medical Center