
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at the safety and side effects of an injection called AdNRGM, and a drug called CB1954.
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 ).
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 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 . 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
You may be able to enter this trial if
Or you have had radiotherapy that aimed to cure your cancer but the cancer has come back but your PSA level is rising
You cannot enter this trial if you
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.
Before you start the trial, you will see the doctor and have some tests. These tests include
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
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.
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
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Mr Prashant Patel
Department of Health
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
University of Birmingham
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”