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

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

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Prostate Cancer (Adenocarcinoma)
• Intervention / Treatment: Diagnostic test: LaserSAFE

• Study Type: Interventional
• Enrollment (Estimated): 693
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo Almeida-Magana, Dr; Phone Number: +44 02076792000; Email: r.magana@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, NW1 2BU
    • Recruiting
    • University College London Hospital NHS Foundation Trust
    • Contact: Greg Shaw, Professor; Phone Number: +44 02034567890; Email: gregshaw@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	Sensitivity of LaserSAFE to detect positive margins in the posterolateral area of the prostate of more than 3 mm compared against final paraffin analysis Sensitivity will be monitored across the trial when the first 150, 300 and 500 participants have been recruited. If sensitivity decreases below 85%, trial methodology will be reviewed and if considered appropriate the trial will be stopped.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy metrics for any size of positive margin	Overall sensitivity, specificity, PPV and NPV of LaserSAFE compared to FFPE analysis for any length of PSM	12 months
Determination of Margin Length Cut-off for Secondary Resection	The study will evaluate the optimal cut-off for positive margin length that should trigger a secondary resection, with the aim of maximising nerve-sparing without compromising oncological safety	12 months
Accuracy metrics for positive margins more than 3 mm	Overall specificity, PPV and NPV of LaserSAFE compared to FFPE analysis for any PSM > 3 mm.	12 months
Residual prostate cancer rate	Rate of residual prostate cancer in secondary resections of the neurovascular bundle	12 months
Rate of positive margins	Prevalence of PSM detected by paraffin analysis in the overall cohort	12 months
Biochemical failure	Prevalence of prostate cancer biochemical recurrence or salvage treatment within 12 months after surgery	12 months
EPIC-26 urinary incontinence mean score	Mean score for EPIC-26 urinary incontinence domain at baseline, 3 and 12 months after surgery Expanded Prostate Cancer Index Composite (EPIC)-26, is a 26-item patient reported outcome, is a continuous scale ranging from 0 to 100, with higher scores indicating better function	12 months
EPIC-26 erectile function mean score	Mean score for EPIC-26 erectile function domain at baseline, 3 and 12 months after surgery Expanded Prostate Cancer Index Composite (EPIC)-26, is a 26-item patient reported outcome, is a continuous scale ranging from 0 to 100, with higher scores indicating better function	12 months

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Greg Shaw, Professor, University College, London

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): May 20, 2030
• Study Completion (Estimated): May 20, 2031

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Prostate cancer; Prostatectomy; Confocal microscopy; Positive margins
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings; Prostatic Neoplasms; Adenocarcinoma; Margins of Excision; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Microscopy; Microscopy, Confocal
• Other Study ID Numbers: 199328; 364428 (Other Identifier: IRAS NIHR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: An anonymised dataset will be made available on a case by case basis to researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No