medwireNews: Using the NeuroSAFE technique to guide robot-assisted radical prostatectomy (RARP) improves functional outcomes 12 months after surgery compared with standard preoperative nerve-sparing planning for the procedure, phase 3 research shows in The Lancet Oncology.
Assessing intraoperative frozen sections of the neurovascular bundle-adjacent prostate margin with the NeuroSAFE technique allows “accurate real-time detection of positive surgical margins during nerve-sparing” but there is a “lack of high-quality evidence of its safety and effectiveness,” explain Greg Shaw (University College London Hospitals NHS Foundation Trust, UK) and co-workers.
To investigate further, the team assessed the impact of the NeuroSAFE technique versus standard RARP care in men with nonmetastatic prostate cancer who required RARP between 2019 and 2022 at one of five UK hospitals. The men all had good erectile function, defined as a score of at least 22 points on the first five items of the International Index of Erectile Function (IIEF)-5, without use of medical assistance.
After a median of 12.3 months of follow-up, the mean IIEF-5 score was 12.7 for the 173 men who were randomly assigned to undergo RARP guided by the NeuroSAFE assessment. This was significantly better than the average score of 9.7 for the 171 men who instead received standard RARP care.
At 12 months, the NeuroSAFE RARP group also had significantly better scores for the erectile function domain of the IIEF-6 measure (15.3 vs 11.5 points). And although the average International Consultation on Incontinence Questionnaire (ICIQ) score was significantly poorer 3 months after surgery with NeuroSAFE than standard RARP (5.8 vs7.4 points), there was no longer a significant difference at 6 months (4.5 vs 5.1 points).
NeuroSAFE RARP took 43 minutes longer on average to perform than the standard procedure (174.4 vs 131.4 minutes), but surgeons were more likely to achieve bilateral nerve-sparing with NeuroSAFE than without (82 vs 56%) and were less likely to not achieve nerve-sparing (1 vs 6%).
The researchers note that bilateral nerve-sparing was not recommended in preoperative planning for 68% of the participants – subgroup analysis indicated that among these men, the IIEF-5 score at 12 months was significantly higher with NeuroSAFE than for standard RARP, but there was no significant difference in ICIQ score between the groups.
The NeuroSAFE and standard RARP groups had a similar number of adverse events (AEs, 20 vs 25) and serious AEs (6 vs 5); all AEs were related to surgery but not to the study procedures, and there were no prostate cancer deaths or surgery deaths.
Overall, 65% of patients who underwent NeuroSAFE had negative margins, as did 72% of controls; NeuroSAFE was associated with a higher rate of small, single positive surgical margins than standard RARP (21 vs 13%) but a similar rate of 3 mm or greater multifocal positive surgical margins (14 vs 16%).
Oncological outcomes at 12 months showed that the NeuroSAFE and control groups had similar rates of prostate-specific antigen persistence (4 vs 3%), biochemical recurrence (6 vs 4%), and requirement for adjuvant therapy (4 vs 1%). Overall, 86% of NeuroSAFE-treated patients had no recurrence or treatment compared with 93% of controls.
“Although our trial was not powered to detect a difference in oncological outcomes, existing long-term data on NeuroSAFE RARP from retrospective cohort studies suggest no significant oncological disadvantage,” the researchers comment.
They say that their trial “confirms the efficacy of the NeuroSAFE technique to improve functional outcomes after RARP in patients with good preoperative urinary and erectile function,” adding that the “findings should inform guideline updates and confirm the role of the NeuroSAFE technique as an adjunct to guide nerve-sparing.”
Nevertheless, while waiting for the 5-year outcomes of the trial, the team says that “patients offered NeuroSAFE should be counselled on its potential functional benefits and the currently unknown impact on the need for additional treatment.”
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Lancet Oncol; doi:10.1016/ S1470-2045(25)00091-9
