A trial looking at a biological therapy to treat prostate cancer that has come back after treatment (AdUP)

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:

Phase 1

This trial is looking at the safety and side effects of an injection called AdNRGM, and a drug called CB1954.

More about this trial

If your prostate cancer comes back after radiotherapy aimed to cure it, you may have hormone therapy to control it. But although hormone therapy can work for a time, the cancer may stop responding at some point (it becomes resistant Open a glossary item ).

In this trial, researchers are looking at a possible treatment to help men in this situation. The treatment is in 2 parts. The first part is an injection called AdNRGM. It is made from a common virus called adenovirus, which usually causes colds and sore throats. Researchers have altered the virus so that it can’t spread. And, have made it produce an enzyme Open a glossary item called nitroreductase (NR).

The injection also contains GM-CSF, which helps the body’s immune system to fight infection. It may help the immune system work against prostate cancer.

The second part of the treatment is a pro drug called CB1954. A pro drug is a drug that only becomes active when given with another substance. In this trial, it is the NR enzyme produced by the virus in the AdNRGM injection that makes CB1954 active.

You have the virus injection into your prostate gland while you are under general anaesthetic Open a glossary item . The next day, you have CB1954 through a drip into a vein. In most cells, CB1954 will remain inactive. But when CB1954 reaches the prostate, the NR enzyme will change it into an active drug that can kill cancer cells. The drug can spread to other nearby cancer cells, even if the virus did not infect them.

The aims of this trial are to

Learn more about the safety of combined treatment with the virus injection (AdNRGM) and the drug CB1954
Find out about any side effects

Who can enter

You may be able to enter this trial if

You have prostate cancer
You have had radiotherapy that aimed to cure your cancer but the cancer has come back and you have had both your testicles removed

Or you have had radiotherapy that aimed to cure your cancer but the cancer has come back but your PSA level is rising

Your PSA level is between 2 and 100
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You have satisfactory blood test results
You are willing to use at least 2 methods of reliable contraception from when you have the trial drugs, for at least 12 months if there is any chance your partner could become pregnant
You are at least 18 years old

You cannot enter this trial if you

Would not be able to have injections into your prostate through the area of skin behind the testicles for any reason – you can ask your doctor about this
You have had internal radiotherapy (brachytherapy) to treat your prostate cancer
You have had the trial drugs before, or taken part in another trial of gene therapy that also used adenovirus in the past 5 years – you can ask your doctor about this
You have had chemotherapy, radiotherapy or immunotherapy in the last 28 days
Are taking steroids or any other drug that dampens your immune system
Have an active infection, including adenovirus
Have hepatitis B, hepatitis C or HIV
Have had any other cancer, unless this was successfully treated at last 3 years ago (if you have had successfully treated non melanoma skin cancer or early bladder cancer within this time you may still be able to take part)
Have any problems with your immune system
Have any other condition or situation that would make it difficult for you to take part in the trial

Trial design

This phase 1 trial aims to recruit about 15 men.

Before you have the trial treatment, you have a dose of antibiotic through a drip into a vein. This is to try to prevent you getting an infection.

You have the AdNRGM injection into your prostate gland while you are under general anaesthetic. The doctor will do this by putting some thin needles through the skin behind your testicles, into your prostate. They then inject the virus and remove the needles. The procedure will take about 2 hours. Afterwards, you stay in hospital for the rest of the day and overnight, so that the nurses can monitor you. You then go home.

You come back to the hospital the next day and have CB1954 through a drip into a vein. You can go home a couple of hours after this.

A trial doctor will phone you at home for the next 2 days to check how you are feeling. You see the trial team regularly after this and have more blood tests, including a PSA blood test.

If you agree, the team would like to take another prostate biopsy about a month after you have the trial treatment. You do not have to have this biopsy if you don’t want to.

The team will ask your permission to store any leftover tissue from this biopsy, and blood from blood samples, in case other approved researchers would benefit from using them in future.

Hospital visits

Before you start the trial, you will see the doctor and have some tests. These tests include

Physical examination
Blood test
Heart trace (ECG )
Ultrasound scan of your prostate
Prostate biopsy
Stool and urine samples
Throat swab

After you have the AdNRGM injections you stay at the hospital for one night. You come back to the hospital 2 days after the virus injection to have CB1954. A month later you have the extra prostate biopsy, if you agree to this.

You see the trial team and have a blood test

About a week after you have the AdNRGM injections
At 2, 3 and 4 weeks after treatment
Every month for a year

The team will pay reasonable travel costs.

A year after you finish the trial you go back to seeing your cancer specialist in the same way you did before.

Side effects

This is the first time that CB1954 and AdNRGM have been used together, so there may be side effects the researchers don’t know about yet. Side effects of CB1954 and AdNRGM we know about so far include

Redness, tenderness, warmth and itching where you have the injection
Feeling sick
Diarrhoea
Flu like symptoms
Tummy pain
Temporary swelling of the prostate – this may mean that you have difficulty passing urine – if this happens you would have a plastic tube put into your bladder (a catheter) for up to 2 weeks to help you until the swelling goes down