PD-L1-expressing Regulatory T Cells in Blood and Urine of Localized Prostate Cancer Patients Undergoing Iodine-125 Permanent Brachytherapy
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- the level of PD-L1-expressing regulatory T cells in blood and urine
研究概览
简要总结
Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer is poorly responsive to immune checkpoint inhibition. The combination of immunotherapy and radiotherapy is an emerging clinical treatment aradigm. X-ray radiation treatment can activate both the adaptive and innate immune systems through directly killing tumor cells, causing mutations in tumor-derived peptides, and causing localized inflammation that increases immune cell trafficking to tumors. Recently, preclinical study reported that immune checkpoint inhibition combined with radiotherapy treats CPRC with significant increases in median survival compared to drug alone.
详细描述
Permanent brachytherapy is one of those standard treatments for localized prostate cancer patients.
Biopsy confirms prostate cancer. Blood and urine of localized prostate cancer patients will be collected before and at different time points after permanent brachytherapy (1, 3, 6, and 12 months)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Biopsy confirms prostate cancer
- •Localized Prostate Cancer, ≤cT3
- •No chemotherapy or Hormonal therapy before Permanent Brachytherapy
排除标准
- •Unacceptable operative risk
- •Poor anatomy which in the opinion of the radiation oncologist could lead to a suboptimal implant (e.g.,large or poorly healed transurethral resection of the prostate (TURP) defect, large median lobe, large gland size).
- •Pathologically positive lymph nodes
- •Significant obstructive uropathy
- •Distant metastases
- •Use steroids regularly
- •The diagnosis was accompanied by immune-related diseases
- •Allergic constitution
- •Abnormal white blood cell and lymphocyte counts
- •Ever underwent other treatments for prostate cancer, such as chemotherapy or Hormonal therapy
- •Accompanied by other malignancies
- •Splenectomy
- •HIV positive
- •Receive an anti-infective vaccine for the last 6 months
结局指标
主要结局
the level of PD-L1-expressing regulatory T cells in blood and urine
时间窗: 2 year
the level of PD-L1-expressing regulatory T cells in blood and urine
次要结局
未报告次要终点
研究者
ou tongwen
chairman of urology
Xuanwu Hospital, Beijing