LaserSAFE: Quick in OR imaging to check margins during prostatectomy
Official title: A Study to Evaluate the Performance of En-face Fluorescence Confocal Microscopy (LaserSAFE) for Margin Analysis During Radical Prostatectomy
Run by University College, London · NCT07541911 · Data updated 2026-11-12
A new in‑the‑operating‑room imaging method called LaserSAFE is tested to see if it can quickly detect cancer at the edge of the prostate during surgery for patients undergoing robot-assisted prostatectomy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 693 (estimated) |
| Sponsor | University College, London Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | May 20, 2030 |
| Study ends | May 20, 2031 |
| Registry record updated | May 18, 2026 |
| Trial ID | NCT07541911 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Men with clinically significant operable prostate cancer (cT2–T3a N0 M0) who are planned for robot-assisted radical prostatectomy and have at least one side recommended against intrafascial nerve sparing based on MRI and clinical factors.
✕Probably not a fit
Patients whose cancer characteristics or anatomy yield inconclusive LaserSAFE results or whose surgery planning is not altered by intraoperative imaging may not receive added benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study evaluates LaserSAFE, a confocal microscopy technique used in the operating room to scan the removed prostate for positive margins. The goal is to determine how accurately LaserSAFE detects cancer at the resection edges and whether it can support decisions about preserving or removing surrounding nerves. Participants are men with clinically significant operable prostate cancer undergoing robot-assisted radical prostatectomy and who are already considered less suitable for nerve-sparing approaches. The study also assesses the speed and reliability of LaserSAFE in providing intraoperative margin information. No traditional randomization or phase designation is listed.
Why it matters
Potential benefit: If successful, LaserSAFE could help surgeons make better intraoperative decisions about nerve preservation, potentially improving functional outcomes without compromising cancer control.
How similar studies have gone: Previous imaging approaches have shown promise in detecting positive margins, but the use of in‑the‑OR confocal microscopy with LaserSAFE for real-time surgical decision‑making is relatively novel and exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
University College London Hospital NHS Foundation Trust
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Greg Shaw, Professor — University College, London
- Study coordinator: Ricardo Almeida-Magana, Dr
- Email: r.magana@ucl.ac.uk
- Phone: +44 02076792000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.