@article{McClintock_Khanani_DeRosa_Leslie_Ahmadi_Fallot_Ferguson_Woo_2021, title={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}, volume={2}, url={https://siuj.org/index.php/siuj/article/view/147}, DOI={10.48083/HAHE3801}, abstractNote={<p><strong>Objectives</strong> To test the hypothesis that a randomised trial of extended pelvic lymph node dissection (ePLND) can<br>recruit at a rate acceptable for a larger scale trial.<br>To compare the following secondary endpoints between the 2 arms: the rate of protocol violations, the intraoperative<br>and postoperative morbidity of ePLND, and complications, and to evaluate short-term oncological outcomes<br>comparing biochemical recurrence, clinical recurrence, and survival between arms.<br><strong>Patients and Methods</strong> A pilot study will be undertaken at Chris O’Brien Lifehouse and Royal Prince Alfred<br>Hospitals for the NODE trial. Twenty patients will be randomised 1:1 to radical prostatectomy with or without<br>ePLND. Eligible participants will have high-risk prostate cancer and will be scheduled for robotic radical<br>prostatectomy. High-risk disease will be defined as in the 2019 NCCN guidelines (stage ≥ T3a, ISUP Grade Group ≥ 4<br>or PSA ≥ 20ng/mL). PSMA PET/CT staging not showing any extraprostatic disease will be required.<br>Quality control measures to ensure consistent delivery of high-quality extended lymph node dissections are in place,<br>and surgeons have been selected for their consistent ability to perform such procedures.<br><strong>Results</strong> The trial is currently underway.<br><strong>Conclusion</strong> On current available evidence, it is unclear if ePLND provides additional benefit over radical<br>prostatectomy.</p&gt;}, number={6}, journal={Société Internationale d’Urologie Journal}, author={McClintock, George and Khanani, Hadia and DeRosa, Antonella and Leslie, Scott and Ahmadi, Nariman and Fallot, Jeremy and Ferguson, Peter and Woo, Henry}, year={2021}, month={Nov.}, pages={370-379} }