Prostate CancerPhase 1/2NCT06398470
Study to Evaluate a New Method to Detect Residual Tumours During Surgery for Prostate Cancer Using Confocal Microscopy
A Phase 1/2 study testing NeuroSAFE procedure and LaserSAFE procedure in people with Prostate Cancer, run by University College, London at 1 site in United Kingdom.
Trial summary
Prostate cancer is the most common solid cancer affecting male patients worldwide. When diagnosed early, it can usually be cured with surgery (radical prostatectomy), but this procedure is associated with side effects such as urinary incontinence and erectile dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- NeuroSAFE procedure and LaserSAFE procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 May 2024to 7 Jan 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 operable cT2-T3a N0 M0 prostate cancer.
- Patients who underwent a multiparametric magnetic resonance imaging (MRI) before or after prostate biopsy.
- Medically fit to undergo radical prostatectomy.
- Scheduled for robot-assisted radical prostatectomy with a recommendation against 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 the patient information sheet and to give informed consent.
Who cannot join
- • Patients who received neo-adjuvant treatment.
- Patients in whom preoperative imaging shows rectal involvement or seminal vesicle invasion in which nerve sparing is deemed not feasible due to 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.
United Kingdom1 site
University College Hospital at Westmoreland Street
London, W1G 8PH
About this study
Official title: A Feasibility Trial to Evaluate Margin Status During Radical Prostatectomy With En-face Fluorescence Confocal Microscopy (LaserSAFE) Compared to NeuroSAFE
Prostate cancer is the most common solid cancer affecting male patients worldwide. When diagnosed early, it can usually be cured with surgery (radical prostatectomy), but this procedure is associated with side effects such as urinary incontinence and erectile dysfunction. If the nerves that surround the prostate are left intact (nerve-sparing), the risk of developing these side effects decreases. However, since these nerves are in intimate contact with the prostate there is a chance of leaving cancer cells behind, with the subsequent need for additional treatments. Sadly, the current methods surgeons use to select patients who can safely be offered nerve-sparing are not very accurate in predicting where the tumour is extending outside the prostate.
NeuroSAFE is a technique that can inform the surgeon if there are tumour cells on the surface of the prostate and indicate the need for removing more tissue during the same operation. However, it requires a specialised team to process the sample in a reasonable amount of time that does not excessively prolong the surgery. Therefore, many centres are not able to perform it.
Read more
A new technology called fluorescence confocal microscopy (LaserSAFE) can be used to examine the surface of the prostate and can identify when cancer is present. Critically, it requires minimal training and resources to produce results in a few minutes and the microscope can be placed in the operating room.
The investigators aim to recruit a group of 20 patients who will undergo radical prostatectomy as a treatment for prostate cancer. The prostate specimen will be analysed using both techniques, but decisions on how much tissue to resect during surgery will depend on the results of NeuroSAFE. This feasibility study will allow us to understand the challenges associated with performing both techniques. This will allow us to plan a larger study to evaluate the accuracy of LaserSAFE.
Read the detailed description
This trial will be a multi-site, single-blinded, prospective, feasibility study. 20 participants will be recruited from 2 centres that have experience performing the NeuroSAFE technique. Participants will undergo a robotic-assisted radical prostatectomy with nerve-sparing guided by the NeuroSAFE technique. Before the prostate is sent for evaluation the LaserSAFE technique will be used to analyse the corresponding posterolateral surfaces of the prostate. Participating pathologists involved in interpreting the results of NeuroSAFE will be blinded to the LaserSAFE results, to avoid influencing standard patient treatment, management, and progression outcomes after radical prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- NeuroSAFE procedure, LaserSAFE procedure
- Keywords
- Radical prostatectomy, Nerve sparing, Surgical margins, Confocal microscopy
- Medical subject headings
- Prostatic Neoplasms, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroSAFE procedureDiagnostic test
Frozen section analysis of the posterolateral surface of the prostate to guide nerve sparing decisions.
LaserSAFE procedureDiagnostic test
Also called Ex vivo fluorescence confocal microscopy
The LaserSAFE procedure is performed using an FCM called the Histolog® scanner developed by Samantree® which can be placed within the operating room. The Histolog® scanner produces digital images with high, micrometre-range resolution and enables the visualization of tissue microstructures down to the cellular level.
| Study group | Role | What they receive |
|---|---|---|
| Radical prostatectomy | Other | The patients will undergo radical prostatectomy with nerve sparing decisions based on the results of the NeuroSAFE technique Receives: Diagnostic Test: NeuroSAFE procedure; Diagnostic Test: LaserSAFE procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessment
Evaluate the feasibility of using the LaserSAFE technique to evaluate margin status during radical prostatectomy compared to the NeuroSAFE technique
Measured: 8 months
Secondary outcomes (1)
Concordance
Concordance between LaserSAFE and NeuroSAFE recommendation on secondary resection during radical prostatectomy
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start15 May 2024
- Primary completion15 Dec 2024
- Study completion7 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The investigators aim to recruit a group of 20 patients who will undergo radical prostatectomy as a treatment for prostate cancer. The prostate specimen will be analysed using both techniques, but decisions on how much tissue to resect during surgery will depend on the results of NeuroSAFE.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
- Investigators
- Greg Shaw, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398470
- Sponsor's protocol ID
- 159477
- Other IDs
- 320973
- Status last verified
- Jan 2025
- First submitted
- 1 May 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are currently no plans to share individual participant data as this is a feasibility study with low number of participants
Publications
Almeida-Magana R, Mendes LST, Dinneen E, Al-Hammouri T, Haider A, Silvanto A, Freeman A, Roberts N, Dickinson L, So CW, Tandogdu Z, Lamb BW, Mayor N, Winkler M, Ahmed H, Shaw G. The LaserSAFE technique for margin assessment during radical prostatectomy: a feasibility study. BJU Int. 2026 Jun;138 Suppl 1(Suppl 1):S22-S30. doi: 10.1111/bju.70092. Epub 2025 Nov 27.
PubMed 41309506
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial to Evaluate Margin Status During Radical Prostatectomy With En-face Fluorescence Confocal Microscopy (LaserSAFE) Compared to NeuroSAFE
- ClinicalTrials.gov ID
- NCT06398470
- Acronym / sponsor ID
- 159477
- Conditions
- Prostate Cancer
- Keywords
- Radical prostatectomy, Nerve sparing, Surgical margins, Confocal microscopy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 15 May 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 7 Jan 2025 (actual)
- First posted
- 3 May 2024 (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.
Prostate cancer is the most common solid cancer affecting male patients worldwide. When diagnosed early, it can usually be cured with surgery (radical prostatectomy), but this procedure is associated with side effects such as urinary incontinence and erectile dysfunction. If the nerves that surround the prostate are left intact (nerve-sparing), the risk of developing these side effects decreases. However, since these nerves are in intimate contact with the prostate there is a chance of leaving cancer cells behind, with the subsequent need for additional treatments. Sadly, the current methods surgeons use to select patients who can safely be offered nerve-sparing are not very accurate in predicting where the tumour is extending outside the prostate.
NeuroSAFE is a technique that can inform the surgeon if there are tumour cells on the surface of the prostate and indicate the need for removing more tissue during the same operation. However, it requires a specialised team to process the sample in a reasonable amount of time that does not excessively prolong the surgery. Therefore, many centres are not able to perform it.
A new technology called fluorescence confocal microscopy (LaserSAFE) can be used to examine the surface of the prostate and can identify when cancer is present. Critically, it requires minimal training and resources to produce results in a few minutes and the microscope can be placed in the operating room.
The investigators aim to recruit a group of 20 patients who will undergo radical prostatectomy as a treatment for prostate cancer. The prostate specimen will be analysed using both techniques, but decisions on how much tissue to resect during surgery will depend on the results of NeuroSAFE. This feasibility study will allow us to understand the challenges associated with performing both techniques. This will allow us to plan a larger study to evaluate the accuracy of LaserSAFE.
Detailed description
This trial will be a multi-site, single-blinded, prospective, feasibility study. 20 participants will be recruited from 2 centres that have experience performing the NeuroSAFE technique. Participants will undergo a robotic-assisted radical prostatectomy with nerve-sparing guided by the NeuroSAFE technique. Before the prostate is sent for evaluation the LaserSAFE technique will be used to analyse the corresponding posterolateral surfaces of the prostate. Participating pathologists involved in interpreting the results of NeuroSAFE will be blinded to the LaserSAFE results, to avoid influencing standard patient treatment, management, and progression outcomes after radical prostatectomy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The investigators aim to recruit a group of 20 patients who will undergo radical prostatectomy as a treatment for prostate cancer. The prostate specimen will be analysed using both techniques, but decisions on how much tissue to resect during surgery will depend on the results of NeuroSAFE.
| Arm | Type | Receives |
|---|---|---|
| Radical prostatectomy | Other | Diagnostic Test: NeuroSAFE procedure, Diagnostic Test: LaserSAFE procedureThe patients will undergo radical prostatectomy with nerve sparing decisions based on the results of the NeuroSAFE technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with operable cT2-T3a N0 M0 prostate cancer.
- Patients who underwent a multiparametric magnetic resonance imaging (MRI) before or after prostate biopsy.
- Medically fit to undergo radical prostatectomy.
- Scheduled for robot-assisted radical prostatectomy with a recommendation against 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 the patient information sheet and to give informed consent.
Key exclusion criteria (3 listed)
- • Patients who received neo-adjuvant treatment.
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 |
|---|---|---|
| NeuroSAFE procedureFrozen section analysis of the posterolateral surface of the prostate to guide nerve sparing decisions. | Diagnostic test | Radical prostatectomy |
| LaserSAFE procedureAlso: Ex vivo fluorescence confocal microscopyThe LaserSAFE procedure is performed using an FCM called the Histolog® scanner developed by Samantree® which can be placed within the operating room. The Histolog® scanner produces digital images with high, micrometre-range resolution and enables the visualization of tissue microstructures down to the cellular level. | Diagnostic test | Radical prostatectomy |
Primary outcome
Feasibility assessment
Time frame: 8 months
Evaluate the feasibility of using the LaserSAFE technique to evaluate margin status during radical prostatectomy compared to the NeuroSAFE technique
1 secondary outcome
Concordance
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 41309506Almeida-Magana R, Mendes LST, Dinneen E, Al-Hammouri T, Haider A, Silvanto A, Freeman A, Roberts N, Dickinson L, So CW, Tandogdu Z, Lamb BW, Mayor N, Winkler M, Ahmed H, Shaw G. The LaserSAFE technique for margin assessment during radical prostatectomy: a feasibility study. BJU Int. 2026 Jun;138 Suppl 1(Suppl 1):S22-S30. doi: 10.1111/bju.70092. Epub 2025 Nov 27.
- Individual participant dataSharing planned: No. There are currently no plans to share individual participant data as this is a feasibility study with low number of participants
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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. This study is not recruiting at the moment.
Greg Shaw 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 Phase 1/2 study testing NeuroSAFE procedure and LaserSAFE procedure in people with Prostate Cancer, 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jan 2025. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessment (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06398470, which also lists 1 linked publication.
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 10 Jan 2025.