The NeuroSAFE PROOF study (An RCT to evaluate the use of frozen section technology to improve oncological and functional outcomes in robotic radical prostatectomy)


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Greg Shaw1,Prabs Rajan2,Prasanna Sooriakumaran3,Tim Briggs3,Senthil Nathan3,Navin Ramachandran3,Alex Freeman3,Chris Brew-Graves4,Norman Williams4,Jim Adshead5,Nikhil Vasdev5,Alex Haese6,John Kelly4
1Barts Cancer Centre and UCLH,2Bartshealth,3UCLH,4UCL,5East and North Herts NHS Trust,6The Martini Klinik

Abstract

Background

Radical prostatectomy is an effective cure for organ confined prostate cancer. Men undergoing radical prostatectomy suffer side effects of incontinence (temporary) and impotence (permanent). Nerve sparing minimises these side effects. However, in the presence of extraprostatic extension, for which there is no reliable preoperative test, nerve sparing can cause positive surgical margin (PSM), necessitating adjuvant radiotherapy which compounds side effects. The NeuroSAFE method uses intraoperative frozen section to check that nerve sparing has not caused a PSM, allowing the nerve to be resected if there is a PSM. 

Method

Men who are potent and continent who undergo radical prostatectomy for prostate cancer will be randomised 1:1 between A- current UK practice (nerve sparing based on MRI scan, clinical examination and biopsy results) and B-NeuroSAFE. An initial internal feasibility phase will lead into a multicentre feasibility study through development of a NeuroSAFE training academy. If randomisation is feasible a full RCT will follow with  primary outcome of proportion of potent/continent men with apparent cure (no PSM and undetectable PSA) at 2 years. Health economic evaluation will be performed.

Results

With initial investment in pathology department infrastructure at UCLH an internal pilot has been performed of 12 cases. In 50% of cases the outcome in terms of number and side of nerves spared was different after NeuroSAFE than what had been planned using current UK practice. A NeuroSAFE working group met for the first time at Lister Hospital in March. The internal feasibility phase will start imminently.

Conclusion

This study will provide level one evidence to inform on the utility of a new surgical technique including a health economic analysis. This technique has the potential to minimise side effects of radical prostatectomy without detriment to oncological control.