Prostate CancerLaserSAFENCT07541911
A Study to Evaluate the Performance of Confocal Microscopy to Detect Positive Margins During Radical Prostatectomy
A study testing LaserSAFE in people with Prostate Cancer and Prostate Cancer (Adenocarcinoma), run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostate Cancer (Adenocarcinoma)
- What is being tested?
- LaserSAFE
- How many people
- 693 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Apr 2026to 20 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital NHS Foundation Trust
London, NW1 2BU
Greg Shaw, Professor, +44 02034567890, gregshaw@nhs.net
About this study
Official title: 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:
Read more
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)
- Being tested
- LaserSAFE
- Keywords
- Confocal microscopy, Prostatectomy, Positive margins, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaserSAFEDiagnostic test
Also called Confocal Microscopy
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
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
Measured: 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
Measured: 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.
Measured: 12 months
Residual prostate cancer rate
Rate of residual prostate cancer in secondary resections of the neurovascular bundle
Measured: 12 months
Rate of positive margins
Prevalence of PSM detected by paraffin analysis in the overall cohort
Measured: 12 months
Biochemical failure
Prevalence of prostate cancer biochemical recurrence or salvage treatment within 12 months after surgery
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start20 Apr 2026
- Primary completion20 May 2030 (estimated)
- Study completion20 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This trial will be a multi-site, prospective, non-randomised cohort study focused on accuracy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 693 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greg Shaw, Professor, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541911
- Sponsor's protocol ID
- 199328
- Other IDs
- 364428
- Acronym
- LaserSAFE
- Status last verified
- May 2026
- First submitted
- 14 Apr 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: An anonymised dataset will be made available on a case by case basis to researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Performance of En-face Fluorescence Confocal Microscopy (LaserSAFE) for Margin Analysis During Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT07541911
- Acronym / sponsor ID
- LaserSAFE / 199328
- Conditions
- Prostate Cancer, Prostate Cancer (Adenocarcinoma)
- Keywords
- Confocal microscopy, Prostatectomy, Positive margins, Prostate cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 693 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 20 May 2030 (estimated)
- Study completion
- 20 May 2031 (estimated)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Model description
- This trial will be a multi-site, prospective, non-randomised cohort study focused on accuracy
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaserSAFEAlso: Confocal MicroscopyThe 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. | Diagnostic test | – |
Primary outcome
Sensitivity
Time frame: 12 months
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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. An anonymised dataset will be made available on a case by case basis to researchers
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Not yet recruitingPhase 3
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Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
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RecruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Greg Shaw, Professor principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LaserSAFE in people with Prostate Cancer and Prostate Cancer (Adenocarcinoma), run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Almeida-Magana, Dr (+44 02076792000, r.magana@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.