2-year data support nerve-sparing technique in prostate cancer surgery

An updated 24-month analysis of the NeuroSAFE PROOF study continues to support robot-assisted radical prostatectomy (RARP) guided by the nerve-sparing NeuroSAFE technique in men with prostate cancer.

“At 24 months, NeuroSAFE-guided RARP demonstrated a sustained benefit in erectile function recovery without compromising oncological outcomes,” noted presenter Dr Ricardo Almeida-Magana from the University College London, UK, at EAU26.

After multiple imputation, the mean International Index of Erectile Function-5 (IIEF-5) score at 24 months was higher with NeuroSAFE-guided RARP than with standard RARP (13.52 vs 11.21), corresponding to an adjusted mean difference of 2.48 (95 percent confidence interval, 0.67–4.30; p=0.008). [EAU 2026, abstract P0613]

Over half (52.7 percent) of the men in the NeuroSAFE arm achieved erectile function recovery (IIEF-5 ≥15); in the standard arm, only a third (35.9 percent) did so.

The NeuroSAFE arm also had higher percentages of participants achieving prostate-specific antigen persistence (3.9 percent vs 2.6 percent) and early salvage treatment (7.2 percent vs 3.2 percent) than the standard arm, but the rates of biochemical recurrence were similar between treatment arms (7.7 percent vs 7.4 percent).

By month 24, the NeuroSAFE arm had fewer men with severe erectile dysfunction than the standard arm (33.6 percent vs 43.5 percent). Also, these rates were half of those reported at 3 months (69.6 percent vs 79.9 percent).

Of note, the proportion of men in the NeuroSAFE arm who did not have erectile dysfunction at 24 months increased sixfold from month 3 (from 4.3 percent to 26 percent). A marked increase was also observed in the standard arm, rising from 1.8 percent at month 3 to 13 percent at month 24.

The gradual reductions in the proportion of men with severe erectile dysfunction and increases in those without across timepoints (3, 6, 12, and 24 months) reflect the sustained improvement in erectile function recovery with the nerve-sparing technique.

Limited evidence

“Nerve-sparing during RARP can decrease the risk of poor erectile function recovery but may result in positive surgical margins,” noted Almeida-Magana.

The NeuroSAFE technique, based on a standardized intraoperative frozen-section analysis of the posterolateral prostate margin to guide nerve-sparing decisions, can improve patient-reported erectile function and urinary continence at 3 months. However, evidence regarding its long-term functional and oncological outcomes remains limited.

Almeida-Magana and colleagues evaluated 407 men with localized prostate cancer who had good erectile function (IIEF-5 ≥21) and preoperative urinary continence. The participants were recruited from five UK referral centres. They were randomized to undergo either standard RARP with preoperatively planned nerve-sparing based on MRI and biopsy findings (n=191), or RARP with nerve-sparing guidance by NeuroSAFE (n=204).

Follow-up completion rates at month 24 were 77.4 percent and 68.6 percent in the NeuroSAFE and standard arms, respectively.

“We have previously reported the primary outcome results [of this trial] evaluating NeuroSAFE against standard RARP, showing improved erectile function at 12 months,” noted Almeida-Magana and colleagues. The primary outcome was evaluated using a linear regression model and adjusted for age, recruitment centre, and baseline IIEF-5 score.

“These current findings further support intraoperative margin assessment using the NeuroSAFE technique as a safe and effective approach to optimize functional outcomes following RARP,” they added.