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

NCT07541911 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 693

Last updated 2026-05-18

No results posted yet for this study

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

Conditions

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 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.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Greg Shaw, Professor · University College, London

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2030-05-20
Completion
2031-05-20

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07541911 on ClinicalTrials.gov