A randomized trial on pelvic lymph node dissection versus no lymph node dissection at radical prostatectomy: Report of a trial in progress.

Abstract

TPS5116 Background: The therapeutic benefit of pelvic lymph node dissection (PLND) in the surgical treatment of localized prostate cancer remains unproven. In this trial we aim to evaluate whether PLND reduces biochemical recurrence rates in clinically localized prostate cancer patients. We are presenting our experience in accrual during our first year of implementing this trial at Memorial Sloan Kettering Cancer Center. Methods: Patients without evidence of positive or suspicious pelvic lymph nodes on pre-operative imaging, and without prior pelvic radiation for prostate cancer are eligible. Following informed consent prior to radical prostatectomy, patients are enrolled onto the trial and surgeons are randomized using a cluster randomization. Surgeons are randomized to perform a PLND vs. no PLND for a 3-month period. Since our trial began accruing in July 2020, we have enrolled 366 patients (51 high risk, 286 intermediate risk, and 29 low risk) out of 996 eligible patients (37%) through January 2022. We have enrolled 168 patients in the PLND arm and 198 patients in the no PLND arm. Table 1 shows the breakdown of patient consent status in each risk group, by randomization assignment. At this stage in the accrual, we do not see evidence of consenting bias among PLND vs. no PLND randomization and risk group. We conclude that a single-center cluster randomized trial can accrue large numbers of patients in a short period of time, allowing for large scale trials to be completed. Currently, our trial is on track to complete accrual within our 5-year goal. Clinical trial information: NCT01407263. [Table: see text]