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A trial of VT464 for men with prostate cancer that is no longer controlled with hormone therapy
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
- Find the best dose of VT464 to give
- Learn more about what happens to the drug in your body
Who can enter
You may be able to join this trial if all of the following apply.
- You have prostate cancer and have had surgery to remove your testicles, or have been having hormone therapy to reduce the level of
testosteronein your body for at least 3 months
- Your cancer was controlled with surgery to remove your testicles or hormone therapy, but the level of PSA in your blood is now rising
- The level of testosterone in your body is very low
- 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 at least 18 years old
- You are willing to use reliable contraception during the trial and for 3 months afterwards if you are sexually active and there is any chance your partner could become pregnant
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
- You haven’t had chemotherapy or drugs called abiraterone or enzalutamide
- You have had enzalutamide and abiraterone and you took them for at least 12 weeks
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
- Have cancer that has spread to your brain or spinal cord (the central nervous system)
- Have had drugs such as ketoconazole, aminoglutethimide or high dose oestrogen in the last month (the trial doctor can advise you about this)
- Have had a treatment called sipuleucel-T (Provenge) in the last month
- Have had
steroidsin the last month (steroid creams and inhalers are allowed)
- Have had another experimental drug in the last 2 weeks
- Have had radiotherapy for symptoms in the last 4 weeks
- Have started taking drugs called bisphosphonates in the last 3 months
- Have a problem with your adrenal glands not working properly
- Have had any other type of cancer in the last 3 years
- Have had a heart attack or stroke in the last 6 months or have certain other heart problems (the trial team can advise you about this)
- Have any other medical condition or mental health problem that the trial team think could affect your taking part
- Are known to have HIV, hepatitis B or hepatitis C
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
- Tremors and twitching of the arms, legs and eyelids
- Feeling tired
- Feeling dizzy and lightheaded
- Feeling or being sick
- Short term memory loss
- Changes in your vision
- Changes in your mental status, including feelings of confusion, difficulty concentrating, low mood, depression
- Dry mouth
- Loss of appetite
- Taste changes
- Bone pain
- Dry, itchy skin
- Skin rash
- Hair loss
The trial team will talk to you about all the possible side effects before you agree to take part.
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.
Professor Johann de Bono