A study looking at a way to assess tissue samples taken during prostate surgery (IP8-FLUORESCE)

Cancer type:

Prostate cancer

Status:

Open

Phase:

Other

This study is looking at a way to assess the clear margins Open a glossary item of tissue samples taken during prostate surgery. 

It is open to men who are having radical prostate surgery Open a glossary item.

More about this trial

Surgery is one of the main treatments for prostate cancer. The tissue the surgeon removes is sent to the laboratory. In the laboratory the pathologist Open a glossary item looks at the sample under a microscope to see whether there is a margin of normal tissue around the cancer. This is called a clear margin. Having a clear margin reduces the chances of the cancer coming back.

To look for the margin the pathologist dyes the tissue sample. The cancer cells take up the dye, but the normal cells don’t. To do this they must prepare the tissue sample, but this takes time. 

In this study, researchers are looking at an imaging technique called fluorescent confocal microscopy (FCM). FCM scans the tissue sample and uses a special dye that lights up when a fluorescent light is shone on it. This technique produces digital pictures in about a minute. 

FCM is already used to look at surgical margins in a type of skin cancer called basal cell skin cancer.

The researchers are asking men who are due to have radical prostate surgery if they are willing to donate their tissue samples.

FCM does not interfere with the dye usually used by pathologist to determine the clear margin. So each tissue sample can be looked at using FCM and in the usual way. The team will compare the results. 

The aim of this study is to find out whether FCM works. And to find out if FCM is as good as, or better than, the usual way to assess a clear margin.

Please note that taking part in this study does not affect your treatment and you may not get any direct benefits from it.

Who can enter

The following bullet points are a summary of the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this study if you are male and the following apply. You:

  • are having radical prostate surgery Open a glossary item to remove your prostate cancer
  • are willing to sign a consent form allowing the study team to use the tissue removed from your surgery
  • are at least 18 years old

Who can’t take part

You cannot join this study if you are having surgery to remove the prostate after previous treatment such as brachytherapy Open a glossary item, radiotherapy, cryotherapy Open a glossary item or high intensity focused ultrasound (HIFU Open a glossary item).

Trial design

You have your radical prostate surgery as planned. The study team will assess the clear margin using FCM. Then the pathologist will assess the clear margin in the usual way.

Hospital visits

There are no extra hospital visits for this study.

Side effects

There are no side effects from this study. 

We have information on:

Location

London

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Mathias Winkler

Supported by

John Black Charitable Foundation
Imperial College Healthcare NHS Trust
The Urology Foundation

If you have questions about the trial please contact our cancer information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

19662

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Last reviewed:

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