NeuroSAFE Guided RARP Improves Function in Localized Prostate Cancer

Key Takeaways

• NeuroSAFE-guided RARP was associated with better 12-month patient-reported erectile function than standard surgery.
• Lower ICIQ scores, indicating better urinary continence, were reported at 3 months, with no significant between-group difference at 6 months.
• Serious adverse events were uncommon and similar between groups, and all were postoperative complications with no deaths attributed to the intervention.

NeuroSAFE-guided robot-assisted radical prostatectomy was linked to better 12-month erectile function than standard robot-assisted radical prostatectomy in men with non-metastatic prostate cancer, with an adjusted mean IIEF-5 difference of 3.18 points. In the NeuroSAFE PROOF phase 3 trial, a multicentre, patient-blinded, randomized, controlled study across five UK National Health Service hospitals, investigators compared intraoperative NeuroSAFE-guided nerve sparing with standard robot-assisted radical prostatectomy in a patient-reported functional analysis. Urinary continence also favored NeuroSAFE early after surgery, although the between-group difference was not significant by 6 months.

Eligible men had non-metastatic prostate cancer suitable for RARP, no prior prostate cancer treatment, and IIEF scores of at least 22 on the first five items without medical assistance. No age limits applied, and patients learned their nerve-sparing status after surgery. Participants were randomized 1:1 to standard RARP or NeuroSAFE-guided RARP, with nerve sparing directed by a preoperative plan or intraoperative NeuroSAFE assessment, and operating teams knew allocation. Among 407 recruited patients, 381 underwent surgery and entered the modified intention-to-treat population, and primary outcome data were available for 344 participants, including 173 NeuroSAFE and 171 standard cases. The primary endpoint was 12-month IIEF-5, and secondary endpoints included 3- and 6-month ICIQ scores and 12-month IIEF-6.

At 12 months, mean IIEF-5 score was 12.7 with NeuroSAFE and 9.7 with standard RARP, for an adjusted mean difference of 3.18 (95% CI 1.62 to 4.75; p<0.0001). Mean IIEF-6 score was 15.3 with NeuroSAFE and 11.5 with standard RARP, with an adjusted mean difference of 3.92 (95% CI 2.01 to 5.83; p<0.0001). At 3 months, the ICIQ score was lower with NeuroSAFE, with an adjusted mean difference of -1.41 (95% CI -2.42 to -0.41; p=0.006). At 6 months, the between-group ICIQ difference was not significant, with an adjusted mean difference of -0.37 (95% CI -1.35 to 0.62; p=0.46). These findings reflected lower ICIQ scores with NeuroSAFE at 3 months but no significant between-group difference at 6 months.

Median follow-up was 12.3 months (IQR 11.8-12.7). Serious adverse events occurred in 6 of 190 patients (3%) with NeuroSAFE and 5 of 191 patients (3%) with standard RARP. All adverse events were postoperative complications, and no serious adverse events or deaths were attributed to the study intervention. The authors concluded that NeuroSAFE was associated with improved 12-month IIEF-5 and short-term urinary continence. They also noted greater erectile-function benefit among patients not otherwise selected for bilateral nerve-sparing by standard practice.