KCT0004555招募中未知
Comparison of salvage hypofractionated accelerated versus salvage radiotherapy for biochemical recurrence after radical prostatectomy (SHARE trial): a prospective, randomized controlled, open-label, multi-center, superiority study
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 288
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- o Limit 至 o Limit（—）
- 性别
- Male
入选标准
- •Patients with histologically diagnosed prostate cancer
- •- Prostate cancer of medium risk groups or higher according to the National Comprehensive Cancer Network (NCCN) guidelines
- •- Adults over 20.
- •- Biochemical recurrence after surgery (Definitions: PSA >0.2 ng/mL, =1.0 ng/mL)
- •- Full body performance ECOG 0-1
- •- Finding suitable haematological examination within 6 months prior to research registration
- •Absolute neutrophil count (ANC) = 1500 cells/mm3
- •Platelets = 50,000 cells/mm3
- •Hemoglobin = 8.0 g/dl
- •- Adequate kidney function within 6 months of study registration
- •Creatine < 2.0 ng/dL
- •- Appropriate liver function within 6 months of research registration
- •total bilirubin < 1.5 X normal maximum
- •alignin aminotransferase or aspartate aminotransferase < 2.5 X normal maximum
- •- preSRT PSA = 1 ng/m
排除标准
- •- Imaging examination of surgical site or clinically identified recurrent findings
- •- If pelvic lymph node transfer is confirmed
- •- If teleconversion is confirmed
- •- In case anti-cancer treatment is performed prior to surgery
- •- Past history of exposure to pelvic radiation
- •- Crucial force that has been treated for prostate cancer in cold treatment and near-field radiation
- •- If treated with cancer other than skin cancer and thyroid cancer, NED f/u can be registered after treatment of existing cancer for more than 5 years
- •- In case of severe shared disease
研究者
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