A study looking at a new way of checking that all the cancer has been removed during surgery for prostate cancer

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Other

This study is looking at a new way of checking that all the cancer has been removed in men having surgery for prostate cancer.

If you have prostate cancer contained within your prostate gland, one of the treatments you may have is surgery to remove the prostate gland (prostatectomy).

It can be difficult for the surgeon to know for sure whether they have removed all of your cancer. After your operation, the removed tissue is routinely looked at more closely by an expert (pathologist Open a glossary item ) in the laboratory. They confirm that the cancer is contained within the prostate gland. They also check that the surgeon has removed a border of tissue around the tumour that does not contain cancer cells. This is called a clear margin.

If there isn’t a clear margin, you are more at risk of the cancer coming back. And you may need further treatment, which may cause more side effects.

Surgeons want to find out whether a new device could help them to look at the cancer they have removed straight away, while you are still in the operating theatre. The device is called a '18F-choline CLI specimen Analyser'. It is a type of scan. CLI stands for Cerenkov Luminescence Imaging and 18F-choline is a radioactive drug that is part of the scan.

If this new device works, it would mean that the surgeon knows whether all of your cancer has been removed while you are still in the operating theatre. If they need to, they can then remove more tissue in the same operation.

The aims of this study are to

Learn more about how the device works and make improvements to it if necessary
Compare the results from the new device with the pathologist's report
Find out if it can be looked at further in a larger trial

You will not benefit directly from this study, but the results may be used to improve treatment for patients in the future.

Who can enter

You may be able to join this study if you are a patient at University College Hospital, London and all of the following apply. You

Have been diagnosed with prostate cancer and you are due to have an operation to remove your prostate gland (prostatectomy)
Have a high risk of your cancer coming back, this means that you have stage T2c prostate cancer or a PSA level of 20 ng/ml or higher, or a Gleason score of between 8 and 10
Are at least 18 years old

You cannot join this study if any of these apply. You

Are allergic to the radioactive tracer 18F choline
Are taking a treatment for gout called colchicine
Have already had treatment directed at your prostate cancer (such as radiotherapy, or HIFU)

Trial design

This is a feasibility study, the researchers need about 30 people to join.

Before your operation, you have an injection of a radioactive drug (tracer) called 18-F choline. This is the same drug people often have before a PET scan. The injection helps to show the doctor where the cancer cells are. The 18-F choline travels around the body to the cancer cells and the cancer cells containing 18-F choline give off a low level light.

The tissue your surgeon removes is placed in the new device (the CLI specimen Analyser). The machine picks up on this low level of light and produces pictures for the doctor to look at.

Your surgeon will carry out your operation in the normal way. When your prostate gland is removed, the researchers will look at it using the new device straight away and again 60 minutes later.

Your surgeon will then send your prostate gland to the laboratory where it will be examined by a pathologist, as it would be as part of your routine treatment.

You have the same treatment for your prostate cancer, whether you take part in this study or not. You will not be told about the results of your CLI specimen Analyser. Your doctor will not know your results until after the study has finished and so they will not use them to make decisions about your treatment.

Hospital visits

Your doctor will ask you to take part in this study during one of your routine appointments before your operation.

You do not have any extra hospital visits as a result of taking part in this study.

Side effects

You are exposed to a small amount of extra radiation as a result of having the18-F choline injection as part of this study.

We are all exposed to a very small amount of background radiation during the course of a normal day. The amount of radiation from this injection is about the same as 5 years of background radiation. The amount of 18-F choline used in this study is the same amount you would have before a PET-CT scan. The trial team will be able to answer any questions you have about this.

The level of radiation in your body will reduce very quickly over a few hours. By the time you go back to the ward, the level of radiation in your body will be safe and you can be visited as normal by friends and family.