NCT01555086Unknown不适用
Prospective Randomized Study to Compare a Limited Versus Extended Pelvic Lymphadenectomy During Prostatectomy
Association of Urologic Oncology (AUO)10 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2011年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- PSA-progress
研究概览
简要总结
This study examines Limited versus extended pelvic lymphadenectomy.
详细描述
This study is meant to show if the extension of lymphadenectomy during prostatectomy has an influence of outcome of patients. Patients with indication to prostatectomy due to prostate cancer will be included.
Both extensions of lymphadenectomy are used in hospitals as a free choice. This study shell show if one method is more effective than the other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as Gleason-Score 7-10 or PSA > 10 ng/ml)
- •locally-operable tumor according to DRU/TRUS
- •negative bone scan
- •negative CT abdomen / pelvis
- •general condition according to Karnofsky >/= 80%
- •written consent of the patient
- •adequate hematological, renal and coagulation physiological functions
- •Patient compliance and geographic proximity to allow adequate follow-up
排除标准
- •Manifest secondary malignancy
- •Secured metastasis by histologically or by imaging
- •Myocardial infarction or stroke within the last 6 months
- •Existing major cardiovascular (grade III - IV according to NYHA), pulmonary (pO2 <60 mmHg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases
- •Severe active or chronic infections (eg pos. HIV-Ab test, HBs-Ag detection in serum and / or chronic hepatitis)
- •severe psychiatric disease
- •prior chemotherapy (allowed is a preoperative antiandrogen therapy ≤ 3 months)
- •previous pelvic radiotherapy
- •Patients in a closed institution according to an authority or court decision
- •People who are in a dependent relationship or working relationship with the sponsor or investigator
- •simultaneous participation in another clinical trial
结局指标
主要结局
PSA-progress
时间窗: 5 years
3-monthly Follow-up with PSA-measurement in blood
次要结局
- Comparison of overall survival(5 years)
- Comparison of morbidity(5 years)
研究者
研究点 (10)
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