Protocol for a Pilot Study of the NODE Trial, a Prospective Multicentre Randomised Trial of Extended Pelvic Lymph Node Dissection for High-Risk Prostate Cancer

Abstract

Objectives To test the hypothesis that a randomised trial of extended pelvic lymph node dissection (ePLND) can recruit at a rate acceptable for a larger scale trial. To compare the following secondary endpoints between the 2 arms: the rate of protocol violations, the intraoperative and postoperative morbidity of ePLND, and complications, and to evaluate short-term oncological outcomes comparing biochemical recurrence, clinical recurrence, and survival between arms. Patients and Methods A pilot study will be undertaken at Chris O’Brien Lifehouse and Royal Prince Alfred Hospitals for the NODE trial. Twenty patients will be randomised 1:1 to radical prostatectomy with or withoutePLND. Eligible participants will have high-risk prostate cancer and will be scheduled for robotic radical prostatectomy. High-risk disease will be defined as in the 2019 NCCN guidelines (stage ≥ T3a, ISUP Grade Group ≥ 4 or PSA ≥ 20ng/mL). PSMA PET/CT staging not showing any extraprostatic disease will be required. Quality control measures to ensure consistent delivery of high-quality extended lymph node dissections are in place,and surgeons have been selected for their consistent ability to perform such procedures. Results The trial is currently underway. Conclusion On current available evidence, it is unclear if ePLND provides additional benefit over radicalprostatectomy.