Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398470
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-01
Brief Title:
Study to Evaluate a New Method to Detect Residual Tumours During Surgery for Prostate Cancer Using Confocal Microscopy
Sponsor:
University College London
Organization:
University College London
Study Overview
Official Title:
A Feasibility Trial to Evaluate Margin Status During Radical Prostatectomy With En-face Fluorescence Confocal Microscopy LaserSAFE Compared to NeuroSAFE
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 320973 | OTHER | IRAS number | None |