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

NCT06398470 | Completed Phase 1

• 2 other identifiers: 159477320973
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer

Keywords

Radical prostatectomy; Nerve sparing; Surgical margins; Confocal microscopy

Outcome Measures

Primary Outcomes (1)

• Feasibility assessment

  Evaluate the feasibility of using the LaserSAFE technique to evaluate margin status during radical prostatectomy compared to the NeuroSAFE technique

  8 months

Secondary Outcomes (1)

• Concordance

  8 months

Study Arms (1)

Radical prostatectomy

OTHER

The patients will undergo radical prostatectomy with nerve sparing decisions based on the results of the NeuroSAFE technique

Diagnostic Test: NeuroSAFE procedure; Diagnostic Test: LaserSAFE procedure

Interventions

NeuroSAFE procedure DIAGNOSTIC_TEST

Frozen section analysis of the posterolateral surface of the prostate to guide nerve sparing decisions.

Radical prostatectomy

LaserSAFE procedure DIAGNOSTIC_TEST

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.

Also known as: Ex vivo fluorescence confocal microscopy

Radical prostatectomy

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead
• University College London Hospitals: collaborator

Study Sites (1)

University College Hospital at Westmoreland Street

London, W1G 8PH, United Kingdom

Location

Related Publications (1)

• 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. 2025 Nov 27. doi: 10.1111/bju.70092. Online ahead of print.

  PMID: 41309506 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Greg Shaw

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: After LaserSAFE, images are acquired, they will be annotated with the study identifier only. Images will be stored and kept until the end of recruitment. Once all specimens have been evaluated using paraffin analysis, a dedicated meeting with the evaluating pathologist will be carried out. A set of images without any patient identifier will be shown in random order. A purposely built document will allow the pathologist to report the images. This meeting will be repeated with every evaluating pathologist until all images have been analysed.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 3, 2024
• Study Start: May 15, 2024
• Primary Completion: December 15, 2024
• Study Completion: January 7, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)