Study to Evaluate a New Method to Detect Residual Tumours During Surgery for Prostate Cancer Using Confocal Microscopy

January 8, 2025 updated by: University College, London

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ricardo Almeida Magana
  • Phone Number: +44 (0)20 7679 8088
  • Email: r.magana@ucl.ac.uk

Study Locations

  • United Kingdom
      • London, United Kingdom, W1G 8PH
        • University College Hospital at Westmoreland Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Radical prostatectomy
The patients will undergo radical prostatectomy with nerve sparing decisions based on the results of the NeuroSAFE technique
Diagnostic test: NeuroSAFE procedure
Frozen section analysis of the posterolateral surface of the prostate to guide nerve sparing decisions.
Diagnostic test: LaserSAFE procedure
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.
Other Names:
  • Ex vivo fluorescence confocal microscopy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
8 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Concordance
Time Frame: 8 months
Concordance between LaserSAFE and NeuroSAFE recommendation on secondary resection during radical prostatectomy
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College, London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University College London Hospitals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Greg Shaw, University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 159477
  • 320973 (Other Identifier: IRAS number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are currently no plans to share individual participant data as this is a feasibility study with low number of participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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