#246 Improving Surgical Margins in Prostatectomy for Prostate Cancer: First-in-patient- Dr. Contieri

FULL TITLE: Improving Surgical Margins in Prostatectomy for Prostate Cancer: First-in-patient Study of a Prostate-Specific Membrane Antigen guided Surgery

This is one of the 2023 KS International Innovation Awards videos selected for inclusion in the Vattikuti Foundation – ORSI Humans on the Cutting Edge of Robotic Surgery Conference, October 6, 7 & 8, 2023 in Ghent, Belgium. Posting does not imply that is has been selected as a Finalist, just that the content will be discussed at the Conference.

Description from the entry: Robotic assisted laparoscopic prostatectomy with the use of a PSMA-targeted near-infrared dye for intraoperative fluorescence-guided surgery

Abstract: Improving Surgical Margins in Prostatectomy for Prostate Cancer: First-in-patient Study of a Prostate-Specific Membrane Antigen guided Surgery

Roberto Contieri-a,b, Hilda A. de Barros-a , Judith A. Stibbe-c, Alexander L. Vahrmeijer-c, Jacobus Burggraaf-c,d, Henk G. van der Poel-a,e

a. Department of Urology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands

b. Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy

c. Department of Surgery, Leiden University Medical Center, Leiden University, Albinusdreef 2, 2333 ZA, Leiden, The Netherlands

d. Centre for Human Drug Research, Zernikedreef 8, 2333 CL Leiden, The Netherlands

e. Department of Urology, Amsterdam University Medical Center, Location VUmc, De Boelelaan 1118, 1081 HV, Amsterdam, the Netherlands

Introduction: Fluorescence-guided surgery utilizing tumor-specific tracers showed promise in enhancing the visualization of cancer cells during surgery. We evaluated the use of OTL78, a PSMA- targeted near-infrared dye, for intraoperative fluorescence imaging (FI) of PSMA-positive PCa.

Methods: Patients with PSMA PET-avid PCa, who were scheduled to undergo RALP with or without ePLND were eligible. Patients received a single intravenous infusion of OTL78, with 3 different dose cohorts: (N=3) 0.06 mg/kg 1-2 hours before surgery, (N=11) 0.03 mg/kg 1-2 hours before surgery, and (N=4) 0.03 mg/kg 24 hours before surgery. RALP was performed using the Da Vinci Si or Xi Surgical System. Laparoscopic near-infrared fluorescence imaging was conducted using the VisionSense near-infrared imaging system. Intraoperative near-infrared FI was done before, during, and after resection of prostate.

Results: Between June 2020, and April 2021, 18 patients were enrolled. Sixteen patients (89%) underwent RALP with ePLND. Eight patients had positive surgical margins, with a total of 11 positive margins. All positive margins contained PSMA-expressing PCa cells. In-vivo FI detected fluorescence signals at the location of 9 out of 11 tumor-positive margins (82%), while ex-vivo FI detected signals in all 11 tumor-positive margins. Twelve patients underwent additional resection of residual fluorescent tissue after prostate removal. Among these, in 3 patients (25%) tumor was found in the additional specimen resected. In 9 (75%) of 12 patients resection of residual fluorescence tissue did not show tumor.

Conclusion: OTL78-guided fluorescence surgery for PSMA-positive prostate cancer may play a role in helping surgeons in achieving complete resections and preserving vital structures during RALP.

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