NCT03196778已完成不适用
Non-Targeted Low Dose Radiotherapy For Recurrent Prostate Cancer
Juravinski Cancer Center1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年9月25日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- PSA response
研究概览
简要总结
Older studies in animals and humans have shown cancer responses to very low doses of whole-body or hemi-body radiation. To study the effects of low doses of radiation in patients with recurrent prostate cancer, investigators will enroll up to 21 patients for 10 fractions of low dose radiation, delivered over 5 weeks. Participants will be followed on study for 12 months, capturing PSA, CBC, QoL and blood samples for immunological analysis.
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of prostate cancer.
- •Having undergone prior prostate surgery or radiotherapy or both.
- •Evidence of recurrence of the disease as demonstrated by rising PSA levels. Patients are eligible if on androgen blockade or hormone naïve.
排除标准
- •Prior treatment with chemotherapy and/or abiraterone and/or enzalutamide and/or radium-
- •Receiving treatment with immunosuppressive medications.
- •Platelet count below 50,000/µl (50 x 109/l) or leukocyte count below 3,000/µl (3 x 109/l) or granulocyte count below 2,000/µl (2 x 109/l).
- •Other medical conditions or co-morbidities which, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
- •Language difficulties which may hinder the patient's ability to complete the trial.
- •Inability of the potential participant to provide consent.
- •Lack of independence in daily living activities and any other conditions which, in the opinion of the Investigator, will hinder the participant's ability to participate and complete the study obligations.
研究组 & 干预措施
Low Dose Radiation
Experimental
Subjects will receive low dose body radiation for 5 weeks.
干预措施: Low Dose Radiotherapy (Radiation)
结局指标
主要结局
PSA response
时间窗: Within 12 months of study treatment
Proportion of patients with a reduction of PSA levels by at least 50%
次要结局
- Quality of Life(Within 12 months of study treatment)
- Immunological changes(Within 12 months of study treatment)
- Adverse Events(Within 12 months of study treatment)
研究者
Ian Dayes
Assoc. Professor, Dept of Oncology
Juravinski Cancer Center
研究点 (1)
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