Safety and Efficacy Study of Hypofractionated Radiotherapy for Localized Prostate Cancer: a Single-arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
研究概览
简要总结
The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.
Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.
Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.
详细描述
The present study will be conducted as a prospective, open-label, single-arm clinical trial.
The patients will receive hypofractionated radiation(54 Gy in 15 daily fractions of 3.6 Gy ). After completion of study treatment, patients were followed up once a month for the first 3 months and once every 3 months after 3 months for a total of 5 years.
The primary endpoints of the study are the toxicities about gastrointestinal (GI),genitourinary (GU) symptoms and erectile dysfunction.The secondary endpoints include progression-free survival (bPFS), local progression-free-survival(LPFS) ,distant metastasis free survival(DMFS) ,overall survival (OS)and quality of life (QoL).
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
- •Age: ≥18 years old;
- •European Cooperative Oncology Group score(ECOG):≤ 2;
- •Patients with pathologically diagnosed prostate cancer;
- •Clinical stage was cTanyN0M0 any Gleason / ISUP group;
- •Expected survival time >5 years;
- •The patient has no contraindications to radiotherapy and is suitable and willing to undergo radiotherapy;
- •Patients who voluntarily accept the experimental study protocol after being informed about the existing treatment options;
排除标准
- •Patients who have received any other early treatment for prostate cancer, including radiotherapy, chemotherapy, focal therapy, etc;
- •a previous history of pelvic and abdominal radiotherapy;
- •Prior hormonal therapy (castration or antiandrogen);
- •Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis;
- •Patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases;
- •Patients with contraindications related to radiotherapy;
- •Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study;
- •Patients unable to provide written informed consent or demonstrate poor treatment compliance
结局指标
主要结局
Incidence of radiotherapy-related gastrointestinal and urogenital tract adverse events
时间窗: 5 years
RTOG / EORTC scale, Common Terminology Criteria for Adverse Events (CTCAE) 5.0, erectile dysfunction.
次要结局
- biochemical progression-free survival (bPFS)(5 years)
- local progression-free-survival(LPFS)(5 years)
- distant metastasis free survival(DMFS)(5 years)
- Quality of life (QoL)(5 years)
- Physical Activity Rank Scale-3 (ARS-3)(5 years)
- Overall survival (OS)(5 years)