Post-Prostatectomy Linac-Based Ultrahypofractionated Radiotherapy for Patients With Localized Prostate Cancer: A Treatment Feasibility and Outcomes Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Early Adverse Events/toxicities experience by Participants
研究概览
简要总结
This phase I study will assess the toxicity profile and efficacy of SBRT (Stereotactic body radiotherapy) in patients with localized prostate cancer who are considered candidates for post-prostatectomy radiation.
详细描述
Radical prostatectomy is a common treatment for localized prostate cancer, patients with a detectable and/or rising PSA after radical prostatectomy may be offered radiation. An increasing number of patients are being referred post-operatively for radiotherapy, which creates an added burden on radiotherapy departments. Therefore, a strategy that could potentially decrease the number of radiotherapy fractions, yet maintain its efficacy, would be highly desirable for patient convenience, cost saving, and resource utilization as long as the toxicity profile is acceptable. This study will be conducted to asses the toxicity and efficacy of Stereotactic body radiotherapy (SBRT) in post-prostatectomy patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically confirmed diagnosis of adenocarcinoma of the prostate status post radical prostatectomy
- •Completed written informed consent
- •Able and willing to complete EPIC, PORPUS, and EQ-5D questionnaires
- •A detectable PSA ≤ 2.0 ng/ml
- •Two consecutive rises in PSA and final PSA > 0.1 ng/ml OR three or more consecutive rises in PSA
排除标准
- •Gross residual disease (per conventional imaging, i.e. CT and/or MRI)
- •Histological or radiological node +ve (N1) or distant metastases (M1)
- •Prior pelvic radiotherapy
- •Contraindications to radical pelvic radiotherapy (e.g. connective tissue disease or inflammatory bowel disease)
结局指标
主要结局
Early Adverse Events/toxicities experience by Participants
时间窗: 6.5 years
Incidence of acute GU and GI toxicities, based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0
次要结局
- Late Adverse Events/toxicities experienced by Participants(6.5 years)
- Quality of Life of participants using the Expanded Prostate Cancer Index Composite questionnaire(6.5 years)
- Health Utilities using The Patient-Oriented Prostate Utility Scale(6.5years)
- Health Utilities using EuroQol- 5 Dimension Questionnaire(6.5years)
- Biochemical disease-free survival(6.5 years)
研究者
Chia-Lin (Eric) Tseng
Principal Investigator, Assistant Professor, Dept of Radiation Oncology Sunnybrook Odette Cancer Centre
Sunnybrook Health Sciences Centre