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.
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