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 without ePLND. 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 radical prostatectomy.

Keywords

• prostate cancer
• radical prostatectomy
• lymph node dissection