Evaluating the Effects of Frozen Section Technology on Oncological and Functional Outcomes at Radical Prostatectomy. (NeuroSAFEPROOF)
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Nerve sparing, NeuroSAFE, Frozen section
Eligibility Criteria
Inclusion Criteria:
- Men opting to undergo RARP for organ confined prostate cancer.
- Potent men (IIEF 22-25 not using PDE5i or other medications or vacuum pump)
- Men who are continent of urine (no self-reported urinary incontinence)
- Has given written informed consent
- Ability to read English sufficiently to answer questionnaires and understand PIS
Exclusion Criteria:
- Unable to undergo robotic prostatectomy
- Known overactive bladder
- Previous treatment for prostate cancer
- Previous/current hormone treatment for prostate cancer
- Nerve sparing deemed futile due to locally advanced disease by surgeon and radiologist
Sites / Locations
- North Bristol NHS Trust
- NHS Greater Glasgow & Clyde
- University College London Hospital
- Nottingham University Hospitals
- Sheffield Teaching Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
NeuroSAFE procedure
Control
These patients will undergo robotic radical prostatectomy with bilateral nerve spare.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.Using a cryostat, 10 micron thick slices will be placed on slides.The entire length of the area of interest will be sampled in this way generating ≈10 frozen sections per side.The slides will be stained with H&E and will be examined by a consultant pathologist.As soon as examination is complete the pathologist will telephone the operating surgeon to give the result.Presence of cancer cells at the margin of resection constitutes a positive margin and the neurovascular bundle on that side will be resected
These patients will undergo robotic radical prostatectomy with a nerve sparing procedure based on surgical planning performed by a consultant radiologist. The mp-MRI will be reviewed by a consultant radiologist along with the details of the prostate biopsy and DRE a decision to perform unilateral, bilateral or non-nerve sparing will be established and recorded in the clinical record form (CRF) for each patient.