A Feasibility Study to Evaluate a New Method Residual Tumours During Surgery for Prostate Cancer Using Confocal Microscopy, the LaserSAFE Feasibility Trial - Trial NCT06398470

Timeline & Enrollment

Primary Outcome

Feasibility assessment

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. If the nerves that surround the prostate are left intact (nerve-sparing), the
 risk of developing these side effects decreases. However, since these nerves are in intimate
 contact with the prostate there is a chance of leaving cancer cells behind, with the
 subsequent need for additional treatments. Sadly, the current methods surgeons use to select
 patients who can safely be offered nerve-sparing are not very accurate in predicting where
 the tumour is extending outside the prostate.
 
 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 during the same operation.
 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.

ICD-10 Classifications