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

盆腔淋巴结清扫（PLND）被认为是检测前列腺癌（PCA）淋巴结转移最可靠的方法。然而，PLND在PCA管理中的作用目前仍存在争议。基于现有的临床预测模型，可以将PCA患者分为盆腔淋巴结转移的低危和高危两组。低风险PCA患者表现出1-2%的隐性转移性疾病风险，因此可以安全地忽略PLND。中高危PCA患者有20-40%的潜在盆腔淋巴结转移风险，因此PLND是合理的。如果要做PLND，它应该尊重前列腺的淋巴引流包括沿着闭孔窝的淋巴结，髂外动脉和髂内动脉。目前，尚不清楚PLND的范围（有限PLND与延长PLND）是否与10年总生存期的获益相关，后者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，一组分子标记将被分析，以确定潜在的预测淋巴结转移的存在，复发的发展和生存。

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.