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Feasibility of Da Vinci SP system on extraperitoneal-approach radical prostatectomy in Taiwan: the initial results of SPEAR-P trial

P. LIN¹, H. Wang², H. Kan¹, S. Pang¹, K. Yu¹, C. Wu¹

¹Chang Gung Memorial Hospital, Linkou Branch, Division of Urology, Department of Surgery, Taoyuan City, Taiwan
²Chang Gung Memorial Hospital, Kaohsiung Branch, Division of Urology, Department of Surgery, Kaohsiung, Taiwan

Introduction:

The Da Vinci SP system is an advanced robotic surgery platform allowing an endoscope and three articulated instruments to enter the body through a single incision while maintaining workspace triangulation. This study evaluates the feasibility of using the Da Vinci SP system for extraperitoneal-approach robot-assisted radical prostatectomy (RaRP) in Taiwan.

Material and methods:

This open-label, single-arm clinical trial (ClinicalTrials.gov Identifier: NCT05403190) enrolled patients with localized prostate cancer eligible for surgical resection. Two surgical techniques, the conventional anterior approach and the Hood technique, were used for RaRP. The primary endpoint was the success rate of RaRP with the Da Vinci SP system without conversion to multiport RaRP or open surgery. Secondary endpoints included perioperative variables, oncological outcomes, and functional outcomes.

Results:

The study achieved a 100% success rate for the primary endpoint. Patients who underwent RaRP with the Da Vinci SP system had lower postoperative pain scores and shorter hospital stays. Additionally, 93.33% did not require a drain tube post-surgery, 80% achieved undetectable PSA levels at six months, and 96.67% regained continence within three months. Due to poor preoperative sexual function, the impact on sexual function was not assessed. Of 19 severe adverse events, 4 (21.05%) were related to RaRP.