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

NCT07541911 | Not Yet Recruiting DMC

• 2 other identifiers: 199328364428
• Study Type: interventional
• Target: 693
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer; Prostate Cancer (Adenocarcinoma)

Keywords

Confocal microscopy; Prostatectomy; Positive margins; Prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Accuracy metrics for any size of positive margin

  12 months

• Determination of Margin Length Cut-off for Secondary Resection

  12 months

• Accuracy metrics for positive margins more than 3 mm

  12 months

• Residual prostate cancer rate

  12 months

• Rate of positive margins

  12 months

Interventions

LaserSAFE DIAGNOSTIC_TEST

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.

Also known as: Confocal Microscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital NHS Foundation Trust

London, NW1 2BU, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Adenocarcinoma; Margins of Excision

Interventions

Microscopy, Confocal

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Microscopy; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Greg Shaw, Professor

  University College, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Almeida-Magana, Dr

CONTACT

+44 02076792000; r.magana@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial will be a multi-site, prospective, non-randomised cohort study focused on accuracy

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): May 20, 2030
• Study Completion (Estimated): May 20, 2031
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

GB (1)