The LaserSAFE feasibility trial
Research type
Research Study
Full title
A feasibility trial to evaluate margin status during radical prostatectomy with en-face fluorescence confocal microscopy (LaserSAFE) compared to NeuroSAFE
IRAS ID
320973
Contact name
Gregory Shaw
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2023/07/149, UCL Data Protection Number
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Prostate cancer is the most common solid cancer affecting male patients worldwide. When diagnosed early, it can usually be cured with surgery (radical prostatectomy), but this procedure is associated with side effects such as urinary incontinence and erectile dysfunction. Sparing the nerves that surround the prostate can decrease the occurrence of both, but may risk leaving cancer cells behind, with the subsequent need for additional treatments. Current methods to plan nerve-sparing have limited accuracy to predict the local extension of the tumour.
NeuroSAFE is a technique that can inform the surgeon if there are tumour cells on the surface of the prostate and indicate the need for removing more tissue. However, it requires a specialised team to process the sample in a reasonable amount of time that does not excessively prolong the surgery. Therefore many centres are not able to perform it.
A new technology called fluorescence confocal microscopy (LaserSAFE) can be used to examine the surface of the prostate and can identify when cancer is present. Critically, it requires minimal training and resources to produce results in a few minutes and the microscope can be placed in the operating room.
We aim to recruit a group of 20 patients who will undergo radical prostatectomy as a treatment for prostate cancer. The prostate specimen will be analysed using both techniques, but decisions on how much tissue to resect during surgery will depend on the results of NeuroSAFE. This feasibility study will allow us to understand the challenges associated with performing both techniques. This will allow us to plan a larger study to evaluate the accuracy of LaserSAFE.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0061
Date of REC Opinion
13 Mar 2024
REC opinion
Further Information Favourable Opinion