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

Official title

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

Overview

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

Interventions

• Diagnostic test 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

Primary outcome measures

• Sensitivity [Time frame: 12 months]

Secondary outcome measures (8)

• Accuracy metrics for any size of positive margin [Time frame: 12 months]
• Determination of Margin Length Cut-off for Secondary Resection [Time frame: 12 months]
• Accuracy metrics for positive margins more than 3 mm [Time frame: 12 months]
• Residual prostate cancer rate [Time frame: 12 months]
• Rate of positive margins [Time frame: 12 months]
• Biochemical failure [Time frame: 12 months]
• EPIC-26 urinary incontinence mean score [Time frame: 12 months]
• EPIC-26 erectile function mean score [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• Patients who received neo-adjuvant ADT.
• MRI informed very low likelihood for extra prostatic extension in the proximity of NVB (Based on EPE Likert 1 score or tumour away from the posterolateral areas of the prostate)
• MRI informed high likelihood for extra prostatic extension in the proximity of NVB (based on Likert 5 score or bulging tumour on MRI T2 images)
• Patients in whom preoperative imaging shows rectal involvement or seminal vesicle invasion in which nerve-sparing is deemed not feasible due to oncological safety concerns.
• Patients who received previous treatment for prostate cancer: External beam radiotherapy, brachytherapy, focal therapy, chemotherapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Single group

Masking

Single blind

Primary purpose

Diagnostic

Study locations

United Kingdom · 1 center

• University College London Hospital NHS Foundation Trust — London

Identifiers

NCT: NCT07541911 · 199328 · 364428

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗