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

• Applicant: Professor Dr. Axel Heidenreich
• Subject Area: Reproductive Medicine, Urology
• Term: from 2013 to 2024
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 222686768

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.

• DFG Programme: Clinical Trials