A study looking at a blood test to help doctors decide the best treatment for advanced prostate cancer (VARIANT 7)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer
Secondary cancers

Status:

Closed

Phase:

Other

This study is looking for a protein called AR-V7 in the blood. It is for people with prostate cancer that has spread to other parts of the body (advanced or metastatic prostate cancer).

More about this trial

Hormone therapy is a common treatment for advanced prostate cancer. It can control or shrink the cancer for some time and reduce symptoms. But hormone therapy can stop working for advanced prostate cancer and the cancer starts to grow again. If this happens, you might have:

Doctors would like to know which of these treatments is better for people with advanced prostate cancer. In this study, they are looking at a blood test to check for the levels of a protein called AR-V7. This is called a biomarker test. 

We know from previous research that people who have AR-V7 in their blood, may be less likely to respond to the next generation of hormone therapy. But doctors want to find out for sure whether checking the amount of AR-V7 can help them decide the best treatment. 

Everyone taking part in this study is put into 1 of the following groups:

  • treatment guided by the AR-V7 test
  • treatment as usual 

The main aim of this study is to find out:

  • if it is possible to do a larger trial looking at the AR-V7 biomarker test
  • if AR-V7 helps doctors decide the best treatment for people with advanced prostate cancer

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 

Who can take part
You may be able to join this study if all of the following apply:

  • you have adenocarcinoma of the prostate (prostate cancer) that has spread to other parts of the body
  • you have very low levels of testosterone Open a glossary item (less than 50 ng/dL) 
  • your cancer got worse (progressed) after the start of your last treatment
  • your doctor thinks that you can have hormone therapy with abiraterone or enzalutamide, chemotherapy with docetaxel or cabazitaxel or a type of internal radiotherapy called radium 223
  • you are at least 18 years old 

As well as all of the above, at least 2 of the following must also apply:

  • you were less than 60 years old at the time of your diagnosis of metastatic prostate cancer 
  • your cancer had spread to the bones at the time of your diagnosis of metastatic prostate cancer
  • you have a Gleason score of 8 to 10. Your doctor can tell you more about this
  • your cancer has spread to the liver or lungs
  • your PSA level has doubled in less than 3 months 
  • you have high levels of an enzyme called alkaline phosphatase 
  • you can’t carry out heavy physical work, but can do anything else or you can’t work and need help to look after yourself (performance status of 1 or less)
  • you have had docetaxel for prostate cancer that keeps growing despite treatment to lower the amount of testosterone (castration resistant prostate cancer)
  • have had abiraterone or enzalutamide for castration resistant prostate cancer

Who can’t take part
You cannot join this study if any of these apply. You:

  • have a small cell or neuroendocrine tumour of the prostate 
  • have another cancer and doctors think that there is a possibility of this cancer coming back or getting worse in the next 2 years
  • have cancer spread in your brain or spinal cord, unless you have had treatment and you no longer have symptoms from it 
  • have had an experimental treatment in the last month 

Trial design

Doctors hope that up to 70 people will agree to take part. This is a randomised trial. Everyone taking part is put into 1 of the following groups by computer:

  • treatment guided by the AR-V7 test
  • treatment as usual 

Neither you nor your doctor can choose which group you are in. 


Treatment guided by the AR-V7 test 
You have a blood test to look for the AR-V7 protein. If the test shows that you have AR-V7 in your blood (AR-V7 positive), you have treatment with one the following:

  • chemotherapy with docetaxel or cabazitaxel 
  • internal radiotherapy with radium 223

If you don’t have AR-V7 in your blood (AR-V7 negative), you have hormone therapy with abiraterone or enzalutamide. 

You have treatment in the same way as if you weren’t taking part in this trial. Your doctor can tell you the details of how you have treatment and what to expect. 

Treatment as usual (standard of care)
You also have a blood test to look for the AR-V7 protein. But neither you nor your doctor will know the result of the test. Your doctor will talk to you about which treatment they think is best for you. It can be:

  • chemotherapy with docetaxel or cabazitaxel 
  • internal radiotherapy with radium 223
  • hormone therapy with abiraterone or enzalutamide

You have treatment in the same way as if you weren’t taking part in this trial. 

Quality of life 
Everyone taking part completes a quality of life questionnaire before the start of treatment and 6 months after the first treatment. 

The questionnaires ask about how you have been feeling and what side effects you have had. It takes about 15 minutes to complete each questionnaire. 

Blood tests
Everyone taking part has 3 extra blood tests. You have the extra blood tests:

  • before the start of treatment
  • 3 months after the start of treatment 
  • 6 months after the start of treatment 

Researchers want to learn more about why some prostate cancers spread to other parts of the body and others don’t. And find out why some treatments work better than others. 

Hospital visits

You see a doctor and have some tests before starting treatment. The tests you have are the same as if you weren’t taking part in this trial. Your doctor can tell you more about the tests you will have. 

You give the blood samples and complete the questionnaires when you are already at the hospital for treatment. So, you won’t have extra visits as part of this study. 

Side effects

You have some extra blood tests as part of this study. Blood tests are very safe but you might have a small bruise where you had the test. 

You may also have side effects from treatment. This is the same as if you weren’t taking part in this trial. We have information about the possible side effects of:

Recruitment start:

Recruitment end:

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.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Mr Rakesh Heer 

Supported by

The Newcastle upon Tyne Hospitals NHS Foundation Trust
National Institute for Health Research
Research for Patient Benefit Programme  
Newcastle Clinical Trials Unit

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15460

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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