Prospective randomized trial on limited versus extendes pelvic lymphadenectomy in prostate cancer patients who undergo radical prostatectomy

盆腔淋巴结清扫术（PLND）被认为是检测前列腺癌（PCA）淋巴结转移的最可靠方法。然而，目前正在讨论国家规划局在预防和控制腐败管理中的作用。根据目前可用的临床预测模型，PCA患者可以分为盆腔淋巴结转移低风险和高风险组。低风险PCA患者表现出1-2%的隐匿性转移性疾病的风险，因此可以安全地省略PLND。中、高危PCA患者隐匿性盆腔淋巴结转移的风险为20-40%，因此PLND是合理的。如果要进行PLND，应始终考虑前列腺的淋巴引流，包括沿闭孔窝、髂外动脉和髂内动脉沿着的淋巴结。目前，尚不清楚PLND的程度-有限与扩展PLND -是否与10年总生存期的获益相关，这将作为这项前瞻性随机对照开放临床III期试验的主要终点进行分析。次要终点是无进展生存期、无转移生存期、安全性和并发症。此外，还将分析一组分子标志物，以确定淋巴结转移、复发和生存的潜在预测因素。

Pelvic lymph node dissection (PLND) is considered the most reliable procedure for the detection of lymph node metastases in prostate cancer (PCA). However, the role of PLND in PCA management is currently under debate. Based on the currently available clinical prediction models, patients with PCA can be stratified in groups with low and high risk to harbour pelvic lymph node metastases. Patients with low risk PCA exhibit a 1-2% risk of occult metastatic disease so that PLND can be safely omitted. Patients with intermediate and high risk PCA harbour a 20-40% risk of occult pelvic lymph node metastases so that PLND is justified. If PLND is going to be performed, it should always respect the lymphatic drainage of the prostate include the lymph nodes along the obturator fossa, the external and the internal iliac artery. Currently, it is unclear if the extent of PLND – limited versus extended PLND – is associated with benefit in 10-year overall survival which will be analysed as primary endpoint in this prospective randomized controlled open clinical phase-III trial. Secondary endpoints are progression-free survival, metastasis-free survival, safety and complications. In addition, a panel of molecular markers will be analysed to identify potential predictors for the presence of lymph node metastases, the development of recurrences and survival.