The LaserSAFE study
Research type
Research Study
Full title
A study to evaluate the performance of en-face fluorescence confocal microscopy (LaserSAFE) for margin analysis during radical prostatectomy
IRAS ID
364428
Contact name
Gregory Shaw
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Z6364106/2025/10/66, UCL Data Protection Registration Number
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Prostate cancer is the most common cancer in male patients. If it is found early, it can be cured with surgery to remove the prostate (radical prostatectomy). However, this procedure can cause side effects such as urine leakage (incontinence) and problems with erections. To reduce these risks, surgeons can preserve the nerves that run alongside the prostate. Unfortunately, if the cancer has spread beyond the prostate, sparing these nerves can leave cancer behind.
Currently, doctors use scans and biopsy results to decide whether it is safe to spare the nerves, but these methods are not very accurate. Therefore, many patients miss out on nerve-sparing when it could have been safe, leading to worse quality of life.
A technique called NeuroSAFE can guide nerve-sparing. During surgery, samples from the edge of the prostate are checked under the microscope. If cancer is seen, the surgeon can remove the nearby nerves straight away. By enabling more patients to receive nerve-sparing safely, NeuroSAFE can improve both early urinary control and sexual function. However, it is complex, time-consuming, and requires a large specialist team, making unfeasible in many hospitals.
A new approach called LaserSAFE may overcome these problems. It uses a type of microscope (fluorescence confocal microscopy) that produces images of tissue directly in the operating room, without the need for a full pathology team. Our preeliminary research has shown that LaserSAFE can be as accurate as NeuroSAFE.
This study will evaluate LaserSAFE further to confirm how well it detects cancer at the prostate edge and to find the best “cut-off” point for when a small amount of cancer may be safe to leave, while still protecting patients from cancer recurrence. If successful, LaserSAFE could make nerve-sparing surgery safer and more widely available, helping men keep both cancer control and quality of life after surgery.REC name
London - Dulwich Research Ethics Committee
REC reference
26/LO/0149
Date of REC Opinion
18 Mar 2026
REC opinion
Further Information Favourable Opinion