Personalised indocyanine‐guided lymphadenectomy for prostate cancer: a randomised clinical trial

Objectives To study the safety and efficacy of a personalised indocyanine‐guided pelvic lymph node dissection (PLND) against extended PLND (ePLND) during radical prostatectomy (RP). Patients and Methods Patients who were candidates for RP and lymphadenectomy, with intermediate‐ or high‐risk prostate cancer (PCa) according to the National Comprehensive Cancer Network guidelines, were enrolled in this randomised clinical trial. Randomisation was made 1:1 to indocyanine green (ICG)‐PLND (only ICG‐stained LNs) or ePLND (obturator fossa, external, internal, and common iliac and presacral LNs). The primary endpoint was the complication rate within 3 months after RP. Secondary endpoints included: rate of major complications (Clavien–Dindo Grade III‐IV), time to drainage removal, length of stay, percentage of patients classified as pN1, number of LNs removed, number of metastatic LNs, rate of patients with undetectable prostate‐specific antigen (PSA), biochemical recurrence (BCR)‐free survival, and rate of patients with androgen‐deprivation therapy at 24 months. Results A total of 108 patients were included with a median follow‐up of 16 months. In all, 54 were randomised to ICG‐PLND and 54 to ePLND. The postoperative complication rate was higher in the ePLND (70%) vs the ICG‐PLND group (32%) ( P < 0.001). Differences between major complications in both groups were not statically significant ( P = 0.7). The pN1 detection rate was higher in the ICG‐PLND group (28%) vs the ePLND group (22%); however, this difference was not statistically significant ( P = 0.7). The rate of undetectable PSA at 12 months was 83% in the ICG‐PLND vs 76% in the ePLND group, which was not statistically significant. Additionally, there were no statistically significant differences in BCR‐free survival between groups at the end of the analysis. Conclusions Personalised ICG‐guided PLND is a promising technique to stage patients with intermediate‐ and high‐risk PCa properly. It has shown a lower complication rate than ePLND with similar oncological outcomes at short‐term follow‐up.