A Study to Evaluate the Performance of En-face Fluorescence Confocal Microscopy (LaserSAFE) for Margin Analysis During Radical Prostatectomy
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
• Patients diagnosed with clinically significant operable cT2-T3a N0 M0 PC.
• Medically fit to undergo RARP.
• Scheduled for robot-assisted RARP with a recommendation against intrafascial nerve sparing on at least 1 side based on multidisciplinary meetings informed by MRI, biopsy result and clinical factors.
• Ability to read English sufficiently to understand PIS and able to give informed consent.