NCT01454037Unknown不适用
Immune Profiles and Circulating Tumor Cell Status Following Prostate Cryotherapy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Cancer recurrence
研究概览
简要总结
The change of immune profiles and existence of circulating tumor cells following prostate cryotherapy may be correlated with the clinical outcome.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age>20 years
- •Histopathology-proven prostate adenocarcinoma
- •Non-metastatic localized disease
- •Subjects have chosen their curative, definitive treatments for prostate cancer prior to enrolling for the study
- •Subjects are willing to sign the informed consent and agree to comply with the study procedures
排除标准
- •Chronic use (> 2 weeks) of > 10 mg/day of prednisone or prednisolone within 2 months of the screening (topical or inhalational corticosteroids are permitted)
- •Concurrent use of immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry
- •Other conditions the investigators think may affect subjects' compliance
结局指标
主要结局
Cancer recurrence
时间窗: 3, 6, 12, 24 months after treatments
Includes: 1. Biochemical (PSA) recurrence according to the ASTRO or Phoenix criteria for patients undergoing cryotherapy (Cryo) or radiotherapy (RT) 2. Prostate biopsy positivity 3. Radiographic evidence of recurrence (CT/MRI, Bone scan, radiographs, etc.) Time to recurrence defined by the either of the above 3 outcome parameters
次要结局
- Quality of life(3, 6, 12, 24months after treatments)
研究者
研究点 (1)
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