Cost-utility of NeuroSAFE-guided RARP Versus Standard RARP in Men with Localised Prostate Cancer in the UK.

BACKGROUND

Robotic radical prostatectomy (RARP) is a standard first-line curative treatment for localised prostate cancer but carries risks of erectile dysfunction and urinary incontinence. The NeuroSAFE technique provides pathological assessment to optimise nerve-sparing whilst avoiding positive surgical margins.

OBJECTIVE

This study evaluated the cost-effectiveness of NeuroSAFE-guided RARP compared with standard RARP.

DESIGN SETTING AND

PARTICIPANTS

A within-trial economic evaluation with a 12-month time horizon was conducted alongside NeuroSAFE-PROOF, a single-blinded, multi-centre, randomised controlled trial. Participants were patients with a diagnosis of non-metastatic prostate cancer deemed suitable to undergo RARP, good erectile function without medical erectile function assistance, and no previous prostate cancer treatment. No age limits were applied.

INTERVENTION: The intervention is the NeuroSAFE-guided RARP.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Costs were assessed from NHS and societal perspectives using patient-level data. Quality-adjusted life years (QALYs) were measured using EQ-5D-5L. Incremental cost-effectiveness ratios (ICERs) and net monetary benefits were estimated. Uncertainty was captured via bootstrapping, missing data were addressed through multiple imputation, and Monte Carlo simulations were undertaken to assess robustness.

RESULTS AND LIMITATIONS: Among 407 randomised patients (NeuroSAFE: 204; standard RARP: 203), NeuroSAFE increased mean total cost (by £827 and £1,000 from NHS and societal perspectives, respectively) and QALYs (by 0.03). ICERs were £26,195/QALY (NHS) and £31,666/QALY (societal). Cost-effectiveness probabilities were 53% and 56% (NHS) and 48% and 56% (societal) at the lower and upper UK willingness-to-pay thresholds. Limitations include substantial uncertainty around estimates, missing data, and potential recall bias from retrospectively collected data. Findings reflect short-term, within-trial estimates and should be interpreted accordingly.

CONCLUSIONS AND PATIENT SUMMARY: NeuroSAFE-guided RARP increased costs and generated modest QALY gains on average. ICERs were within the upper UK threshold, although substantial uncertainty remained. These findings reflect 12-month within-trial economic outcomes and should not be interpreted as evidence of long-term cost-effectiveness.