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Outcomes of fluorescence supported lymph node dissection in robot-assisted radical prostatectomy – a prospective randomized clinical trial

Abstract: PD10-01
Sources of Funding: None

Introduction

The detection of lymph node metastases has a major impact on patients with prostate cancer. However, there is still a debate on the extent of pelvic lymphadenectomy, the usage of near-infrared fluorescence (NIRF) and sentinel node dissection in radical prostatectomy. This study aims to demonstrate the outcomes of NIRF lymph node dissection in robot-assisted radical prostatectomy._x000D_

Methods

120 patients with intermediate (72%) or high risk (28%) prostate cancer were prospectively randomized (1:1): in the intervention group indocyanine green (ICG) was injected transrectally into the prostate before docking of the robot. In both groups an extended pelvic lymph node dissection (ePLND) was performed including eventual dissection of fluorescent lymph nodes (LN) in the ICG group. _x000D_

Results

After exclusion of two drop-outs, 59 patients were allocated in the control (A) and intervention group (B) with a median PSA of 8,6 ng/ml. Median console time was 159 (A) vs. 168 (B) minutes (p=0,20) with a longer time for NIRF ePLND: 43 (A) vs. 55 minutes (B) (p=0,001). Overall, 2609 LN (median 22 LN) were found. In the ICG group 582 fluorescent LN were identified, while 899 were non-fluorescent. Significantly more LN could be harvested in B with median 25 LN vs. 17 in A (p<0,001). In 6 of the 59 patients in the intervention group, 19 additional fluorescent LN were found outside of the routine ePLND field. 15 out of 118 patients presented 87 nodal metastases. These metastases were detected in 6 patients in A (25 cancerous LN) vs. 9 patients in B (62 positive LN) (p=0,40). In 7 of 9 patients, NIRF ePLND identified at least one cancer-positive LN (sensitivity 78%), although 35 of 62 cancerous LN were non-fluorescent. No adverse reactions to ICG, no significant differences in complication rates (p=0,15); lymphocele occurred in one patient in A and in three patients in B (p=0,62). After six months, 5,8% vs. 3,7% showed a PSA>0,2 ng/ml (p=0,37) with a median PSA of 0,01 ng/ml in both groups (p=0,96). There was no difference in adjuvant therapy with 10 patients undergoing radiation therapy, 7 patients with androgen deprivation therapy (ADT) and 3 patients with combined radiation and ADT (p=0,78)._x000D_

Conclusions

Without increased risk for the patient, NIRF ePLND leads to a significantly higher yield of lymph nodes. While it therefore seems to be beneficial with regard to a better understanding of the lymphatic drainage and a more meticulous diagnostic approach, the sensitivity seems not to be sufficient to recommend stand-alone NIRF sentinel lymph node dissection._x000D_

Funding

None

Authors
Nina Harke
Christian Wagner
Katarina Urbanova
Michael Godes
Mustapha Addali
Bernhard Fangmeyer
Andreas Schuette
Jorn H. Witt
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