NeuroSAFE PROOF feasibility study – improving erectile function recovery for men undergoing radical prostatectomy for localised prostate cancer


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Eoin Dinneen, Jack Grierson, Aiman Haider, Alex Freeman, Jon Oxley, Tim Briggs, Senthil Nathan, Norman Williams, Chris Brew-Graves, Raj Persad, Jon Aning, Charlie Jamieson, Marzena Ratynska, Imen Ben-Salha, Rhys Ball, Rosie Clow, Clare Allen, Dan Heffernan-Ho, John Kelly, Greg Shaw

Abstract

Background


Radical prostatectomy (RP) is an effective treatment for localised prostate cancer, and approximately 8,000 men undergo robot-assisted radical prostatectomy (RARP) every year in the UK.  However, this surgery inflicts considerable damage on a man’s erectile function.  The NeuroSAFE technique aims to promote erectile function recovery in men undergoing RARP by facilitating increased preservation of the closely adherent neurovascular bundles during surgery (known as nerve-sparing).  The NeuroSAFE technique has never been formally evaluated by any prospective trial to date.                    


Method

The NeuroSAFE PROOF feasibility study (NCT03317990; regional ethics committee reference 17/LO/1978 ) was the first randomised controlled trial (RCT) of the NeuroSAFE technique in the world.  The primary outcome was to demonstrate the feasibility of a larger definitive RCT by recruiting 50 men over 18 months at more than one uro-oncology centre.  Secondary outcomes included peri-operative complications, rates of nerve-sparing, functional outcomes at 12-months, and oncological outcomes at 12-months. 

Results

Between May 2018 and March 2019 49 men at 2 UK centres underwent RARP.  25 men were randomised to NeuroSAFE RARP (intervention arm) vs. 24 men to standard RARP (control arm).  There were no Clavien-Dindo Grade ≥3 complications.  With regards to nerve-sparing performed during surgery, 15 men (62.5%) had  bilateral intrafascial (i.e. best quality) nerve-sparing in the NeuroSAFE arm vs. 8 men (33%) in the control arm.

Conclusion

The NeuroSAFE PROOF trial is feasible and indeed recruitment to the full study is well underway with over 150 of a target 404 men already recruited to date.  Increased nerve-sparing rates during surgery in the intervention arm is encouraging, though patient reported outcome measures on functional status and long-term oncological outcomes matter most to patients.  These long-term important patient-centred outcomes are currently being collected in the definitive NeuroSAFE PROOF study.

Impact statement

The results of the NeuroSAFE PROOF feasibility study are encouraging and pave the way for the full NeuroSAFE PROOF study, which will give hitherto unparalleled information about the ability of the NeuroSAFE technique during RARP to improve patient recovery.