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A Study to Evaluate the Performance of Confocal Microscopy to Detect Positive Margins During Radical Prostatectomy
Sponsor: University College, London
Summary
The goal of this study is to find out whether a new method called "LaserSAFE" can accurately detect cancer at the edge of the prostate (called a positive margin) during prostate surgery. LaserSAFE uses a special microscope in the operating room to quickly scan the prostate after it has been removed from the body. This information can help surgeons decide whether it is safe to preserve the nerves around the prostate. This is especially important for patients who are not usually considered suitable for nerve-sparing surgery using current methods. The study will also assess how quickly and reliably LaserSAFE provides this information during surgery. The main questions it aims to answer are: Can LaserSAFE accurately detect cancer at the edges of the prostate during surgery? Can LaserSAFE help surgeons safely decide whether to preserve or remove the surrounding nerves? Researchers will evaluate the use of the LaserSAFE technique during surgery to see if it improves decision-making about nerve preservation compared to standard practice. Participants will: Complete a quality of life questionnaire before surgery Undergo standard prostate surgery, where the surgeon will initially try to preserve the nerves Have their removed prostate analysed during surgery using the LaserSAFE technique Have additional tissue removed if LaserSAFE detects cancer at the edges of the prostate Attend routine follow-up visits as part of standard care Complete quality of life questionnaires at 3 and 12 months after surgery
Official title: A Study to Evaluate the Performance of En-face Fluorescence Confocal Microscopy (LaserSAFE) for Margin Analysis During Radical Prostatectomy
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
693
Start Date
2026-04-20
Completion Date
2031-05-20
Last Updated
2026-04-21
Healthy Volunteers
No
Interventions
LaserSAFE
The LaserSAFE intervention uses the Histolog® fluorescence confocal microscope to provide real-time tissue visualization at near-cellular resolution. The CE/UKCA/FDA-approved system uses non-ionizing 488nm laser light to capture high-resolution images of areas up to 48×36mm in approximately 60 seconds. Specimen preparation involves cleaning the excised prostate, staining with Histolog Dip® solution for 10 seconds, rinsing with saline, and positioning on the scanner. Both posterolateral surfaces are imaged sequentially, with total acquisition under 5 minutes before standard formalin processing. Image interpretation by trained pathologists identifies positive surgical margins (PSMs), documenting margin dimensions and multifocality. Findings are communicated intraoperatively to guide nerve preservation decisions. Secondary resection of the ipsilateral neurovascular bundle is performed when posterolateral PSMs exceed 3mm (single margin) or multiple PSMs are detected.
Locations (1)
University College London Hospital NHS Foundation Trust
London, United Kingdom