Led by Dr. Eoin Dinneen of University College London, the multicenter phase 3 randomized trial compared outcomes between patients receiving standard RARP and those undergoing NeuroSAFE-guided RARP. The NeuroSAFE technique involves a standardized frozen section analysis during surgery, allowing real-time assessment of surgical margins to facilitate precise nerve-sparing decisions—a key factor in preserving sexual function.
A total of 381 men with good preoperative erectile function and no prior prostate cancer treatment were enrolled in the trial and randomly assigned to either the standard (191 patients) or NeuroSAFE-guided (190 patients) RARP group. At 12 months post-surgery, data from 344 patients showed notably higher scores in erectile function for those in the NeuroSAFE group. Specifically, scores on the IIEF-5—a key measure of erectile health—averaged 12.7 in the NeuroSAFE group versus 9.7 in the standard group. Similarly, the IIEF-6 scores showed a meaningful difference (15.3 vs. 11.5) in favor of the NeuroSAFE technique.
Urinary continence, another crucial post-surgical outcome, also showed early benefits. At 3 months, patients in the NeuroSAFE group reported significantly better scores on the International Consultation on Incontinence Questionnaire (ICIQ), although the difference diminished by the 6-month mark.
Importantly, the safety profile of both approaches remained consistent, with serious adverse events occurring in just 3% of patients across both groups. These findings underscore the added value of the NeuroSAFE technique without introducing additional risk.
“These findings should inform guideline updates and confirm the role of the NeuroSAFE technique as an adjunct to guide nerve-sparing,” the authors concluded, suggesting a potential shift in the standard of care for prostate cancer surgery.
One of the study's authors disclosed a relationship with Intuitive Surgical, a manufacturer of robotic surgical systems.
As more patients and clinicians seek optimal outcomes balancing cancer control with quality of life, the NeuroSAFE approach could mark a new era in prostate cancer treatment.