
"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 drug called VT464 for prostate cancer that is no longer controlled with hormone therapy.
Prostate cancer needs male hormones such as testosterone in order to grow. Testosterone is produced by the testicles. Doctors can treat prostate cancer with hormone therapy to reduce the level of testosterone in your body, or you may have surgery to remove your testicles.
These treatments can control the cancer for some time, but after a while it may start to grow again. Researchers are looking for new treatments to help men in this situation. In this trial they are looking at a drug called VT464.
VT464 reduces the amount of testosterone and other male hormones in the body. This can slow the growth of prostate cancer or shrink it.
The aims of this trial are to
You may be able to join this trial if all of the following apply.
There are 2 parts to this trial. It is now recruiting men to the 2nd part. You may be able to join if you are in 1 of the following situations
As well as the above, if you have taken a drug that stops testosterone reaching cancer cells (such as flutamide or bicalutamide) for more than 3 months, you must have stopped taking it at least 6 weeks ago and your PSA level must have gone up since then. If you have taken 1 of these drugs for less than 3 months, you must have stopped taking it at least 2 weeks ago.
If you have taken a drug such as finasteride or dutasteride, you must have stopped taking it at least 3 months ago.
You cannot join this trial if any of these apply. You
This international trial is in 2 parts. The 1st part of the trial looked at different doses of VT464. This has finished and the researchers now need about 100 men to join the 2nd part.
In the 1st part of the trial, the researchers were studying the safety and tolerability of VT 464.
If you join the 2nd part of the trial, you take VT464 tablets once a day, every day, with your evening meal. The trial team may either increase or lower your dose. They will discuss this with you.
As long as you don’t have bad side effects, you can carry on taking the tablets for as long they are helping you.
You see the trial team and have some tests before you start treatment. The tests include
When you have been taking the tablets for 2 weeks, you go back to see the trial team. They will examine you and ask about any side effects you’ve had and how well you’re able to carry out your normal daily activities. You’ll also have blood tests and 3 heart traces.
2 weeks later, you go back to see the trial team to talk about any side effects you’ve had and how well you’re able to carry out your normal daily activities. They will explain which other tests and scans you need to have at each of your hospital appointments. You then see the trial team once every 4 weeks for the rest of the time you have treatment.
When you finish the treatment, you’ll see the trial team again. They will examine you and ask about any side effects you’ve had and how well you’re able to perform your normal daily activities. You will also have blood tests, a urine test and 3 heart traces.
As VT464 is a new drug, there may be side effects we don’t know about yet. In trials so far, the most common side effects have been
The trial team will talk to you about all the possible side effects before you agree to take part.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Johann de Bono
Innocrin Pharmaceuticals
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.”