A Study to Evaluate the Performance of En-face Fluorescence Confocal Microscopy (LaserSAFE) for Margin Analysis During Radical Prostatectomy

What this Trial Is About

Researchers are evaluating a new technique called LaserSAFE to detect cancer at the edges of the prostate during surgery for prostate cancer. The study focuses on whether LaserSAFE can help surgeons decide if it is safe to preserve the nerves around the prostate, especially in patients usually not considered for nerve-sparing surgery. The study also examines how quickly and reliably LaserSAFE provides this information during the operation. The LaserSAFE technique uses a special fluorescence confocal microscope to scan the removed prostate tissue in the operating room within about five minutes. The prostate is prepared by cleaning, staining with a special solution, rinsing, and then scanned on both sides. Trained pathologists interpret the images to identify any cancer at the surgical margins and communicate results during surgery. If cancer is detected beyond certain limits, additional tissue including nerves may be removed. Participants will complete quality of life questionnaires before surgery and at 3 and 12 months after. They will undergo standard robot-assisted prostate surgery with nerve-sparing attempted initially, with LaserSAFE guiding any further tissue removal. Routine follow-up visits will be part of standard care. Researchers will measure outcomes including the accuracy of LaserSAFE in detecting positive margins, cancer rates after surgery, urinary incontinence, and erectile function over 12 months.

A Study to Evaluate the Performance of Confocal Microscopy to Detect Positive Margins During Radical Prostatectomy