407
Participants
Start Date
April 9, 2018
Primary Completion Date
April 30, 2024
Study Completion Date
December 31, 2027
NeuroSAFE procedure
When the prostate is removed from within the patient as it is disconnected from its attachments. The specimen will then be painted (right=blue, left =black) by the operating surgeon and delivered expediently to the pathologist who will perform frozen section analysis of the painted areas. The pathologist will remove the pre-painted surface of the gland (which had been in contact with the neurovascular bundles) using a sharp blade. The tissue sample will be snap frozen and embedded in OCT. If a significant positive margin (on more than one section from one side or in a single section but greater than or equal to 3mm) is reported by the pathologist, the entire neurovascular bundle on the affected side will be removed and sent for formal pathological examination.
Standard RARP
Patients will undergo the standard intervention - RARP without NeuroSAFE Frozen section analysis
North Bristol NHS Trust, Bristol
NHS Greater Glasgow & Clyde, Glasgow
Nottingham University Hospitals, Nottingham
University College London Hospital, London
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield
North Bristol NHS Trust
OTHER
Sheffield Teaching Hospitals NHS Foundation Trust
OTHER
University College London Hospitals
OTHER
NHS Greater Glasgow and Clyde
OTHER
University College, London
OTHER