Posted: Wednesday, October 19, 2022
A profile of the NeuroSAFE PROOF study presented in Trials describes a randomized comparison of traditional versus NeuroSAFE robotic radical prostatectomy techniques. The NeuroSAFE method involves the evaluation of a frozen section of the neurovascular structure found next to the prostate margin.
“NeuroSAFE PROOF is the first [randomized controlled trial] of intraoperative frozen section during radical prostatectomy in the world,” noted Greg Shaw, MD, of University College London, and colleagues. “It is properly powered to evaluate a difference in the recovery of [erectile function] for men undergoing [robotic radical prostatectomy] assessed by patient‐reported outcome measures. It will provide evidence to guide the use of the NeuroSAFE technique around the world.”
The randomized controlled trial will assign patients on a one-to-one basis to undergo robotic radical prostatectomy using either the NeuroSAFE technique or the standard method. The NeuroSAFE technique may allow surgeons to perform a real-time pathologic consult resulting in improved preservation of neurovascular bundles, which is associated with improved functional outcomes, and avoidance of positive surgical margins, which are associated with adverse oncologic outcomes. The primary outcome is erectile function at a follow-up of 12 months; secondary outcomes include urinary continence at a follow-up of 3 months, erectile function recovery at a follow-up of 24 months, and changes in quality of life. The primary endpoint is the percentage of patients who reach an International Index of Erectile Function score of at least 21.
Feasibility study recruitment ran from October 2017 through December 2018 and opened definitive study recruitment in January 2019. At this time, 230 patients have been enrolled in the trial. The target sample size of 404 patients is meant to result in 90% power to detect a 14% difference between the two study arms. Recruitment is expected to be completed in December 2022.
Disclosure: For full disclosures of the study authors, visit trialsjournal.biomedcentral.com.