Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy.

NAActive, not recruitingINTERVENTIONAL
Enrollment

407

Participants

Timeline

Start Date

April 9, 2018

Primary Completion Date

April 30, 2024

Study Completion Date

December 31, 2027

Conditions
Prostate Cancer
Interventions
PROCEDURE

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.

PROCEDURE

Standard RARP

Patients will undergo the standard intervention - RARP without NeuroSAFE Frozen section analysis

Trial Locations (5)

BS10 5NB

North Bristol NHS Trust, Bristol

Unknown

NHS Greater Glasgow & Clyde, Glasgow

Nottingham University Hospitals, Nottingham

NW1 2BU

University College London Hospital, London

S10 2JF

Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield

All Listed Sponsors
collaborator

North Bristol NHS Trust

OTHER

collaborator

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

collaborator

University College London Hospitals

OTHER

collaborator

NHS Greater Glasgow and Clyde

OTHER

lead

University College, London

OTHER