Hypofractionated Radiotherapy for Prostate Cancer in 20 Sessions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Treatment-related adverse events assessed by CTCAE v4.0
研究概览
简要总结
Radiotherapy is a standard definitive treatment for men with localized prostate cancer.
Recent improvements in technology allow high doses of radiation to be delivered to the prostate in less days with lower doses to surrounding healthy tissues, trying to reduce side effects.
This study is being proposed to evaluate the use of moderate hypofractionated volumetric radiotherapy in localized prostate cancer patients and assessing treatment -related later adverse events using the CTCAE 4.0
详细描述
Recent evidence suggests that the same or better outcomes might be achieved in prostate cancer by ussing a higher dose of radiation per fraction ( 3Gy) with the consequent decrease in total days Quality of life outcomes as well as gastrointestinal and genitourinary late toxicities will be analyzed.
It is thought that this regimen will produce comparable findings and would result in substantial health care cost savings, as well as, be more convenient for patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histologic confirmation of adenocarcinoma of the prostate by biopsy
- •Performance Status 0-2
- •Signed informed consent form
排除标准
- •Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
- •Anticoagulant treatment, individual assessment of antiplatelet therapy
- •Previous pelvic radiotherapy
- •Previous surgery for prostate cancer
- •Previous transurethral resection of the prostate
- •History of Crohn's Disease or Ulcerative Colitis
- •Antecedents of rectal fistulas in the last 10 years
- •Previous significant urinary obstructive symptoms
- •Previous chemotherapeutic treatments
- •Non-compliance with constraints established in this protocol (see special section
结局指标
主要结局
Treatment-related adverse events assessed by CTCAE v4.0
时间窗: Participants should be followed continuously, for the duration of 10 years
Number of patients with treatment-related adverse events as assessed by Common Toxicity Criteria for Adverse Effects v4.0
次要结局
- Biochemical relapse free survival(Participants should be followed continuously, for the duration of 10 years)
研究者
Nicolas Feltes
Principal Investigator
Consorci Sanitari de Terrassa