A trial of VT464 for men with prostate cancer that is no longer controlled with hormone therapy

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 1/2

This trial is looking at drug called VT464 for prostate cancer that is no longer controlled with hormone therapy.

More about this trial

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 testosterone in 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 steroids in 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

Trial design

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.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Blood tests
Urine test
CT scan or MRI scan
Bone scan
3 heart traces (ECGs )

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.

Side effects

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
Fainting
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
Constipation
Diarrhoea
Dry mouth
Heartburn
Loss of appetite
Taste changes
Bone pain
Headache
Dry, itchy skin
Skin rash
Hair loss