A study looking at the effect of AZD2014 before surgery to remove prostate cancer (CaNCaP02)

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

This study is looking at the effect of having a drug called AZD2014 before surgery to remove prostate cancer. It is for men who have prostate cancer that is contained within the prostate and are going to have surgery to remove their prostate gland (a radical prostatectomy).

More about this trial

AZD2014 is a type of biological therapy. It works by blocking the action of a protein called mTOR which helps to control how cells grow.

Cells usually divide and grow in an orderly way. But in cancer cells, proteins such as mTOR can behave abnormally and the cells grow out of control. If mTOR is blocked, this may stop or slow the growth of the cancer.

In this study, you take AZD2014 for about 2 weeks before you have surgery. Taking part in the study will not delay your surgery.

The researchers will compare samples of your cancer taken before starting AZD2014 with a sample of cancer removed during surgery. The aims of the study are to

See what effect the drug has on prostate cancer cells
Find out more about the effect it has on your body (pharmacodynamics )

Who can enter

You may be able to join this study if all of the following apply. You

Have prostate cancer and have decided to have surgery to remove your prostate gland (a radical prostatectomy)
Have cancer that is considered to have a high or intermediate risk of growing or spreading (your doctor can advise you about this)
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception during the trial and for 6 months afterwards

You cannot join this study if any of these apply. You

Have had major surgery in the last 4 weeks, or minor surgery in the last 2 weeks
Are known to be very sensitive to AZD2014 or anything it contains
Can’t swallow tablets or have a problem with your digestive system that could affect how you absorb the study drug
Have had any other cancer in the last 5 years and you had a treatment that reached your whole body (systemic treatment ). You can take part if you had surgery or radiotherapy
Have had a heart attack in the last year or have certain other heart problems (the study team can advise you about this)
Take other medication that can affect your heart rhythm or have an effect on body substances called cytochrome P (CYP) enzymes (the trial team can advise you about this)
Have any other serious medical condition that isn’t controlled with medication (the study team can advise you about this)
Have had growth factors for blood cells such as G-CSF in the last 4 weeks
Have taken part in a trial looking at another experimental anti cancer treatment in the last 5 years

Trial design

This is a phase 1 trial. The researchers need 20 men to join. Everybody in the trial takes AZD2014.

You will have already had a biopsy to diagnose prostate cancer. The researchers will get a sample of this tissue. If there isn’t enough tissue left from your original biopsy, you may need to have another one. Before you agree to take part, the study team will tell you if it is likely that you will need to have another biopsy.

You take AZD2014 tablets twice a day until the morning of your operation. This means you will take them for about 2 weeks. You mustn’t eat anything for at least 2 hours before taking your tablets, and for at least 1 hour afterwards.

While you are taking AZD2014, you also take a drug called ranitidine each night. This limits the amount of acid produced in your stomach and will help to stop the acid indigestion (acid reflux) that AZD2014 can cause.

The study team will give you a diary to complete at home. In this, you keep an accurate record of when you take the tablets.

On the day you have surgery, you have another prostate biopsy. The study team will also get a sample of cancer from your prostate gland after it has been removed. They will send all the samples they take to a central laboratory. Researchers will look for any changes that may have been caused by the AZD2014.

You also give a number of blood samples before and during treatment. The researchers will study these to learn more about what happens to AZD2014 in your body and how it affects you.

Hospital visits

If you take part in this study you will have between 1 and 2 extra outpatient appointments.

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

Physical examination
Blood tests
Urine test
Heart trace (ECG )
Heart scan (echocardiogram )
Chest X-ray

You may also have a CT scan of your chest.

While you are taking AZD2014, you have a blood test each week. Where possible, the study team will take the samples at the same time as you have other routine blood tests.

Some of the blood tests are to check the amount of glucose in your blood. On the days that you have these tests, you mustn’t eat or drink anything (apart from water) for a few hours before getting to the hospital. The study team will tell you what time you will need to stop eating before each appointment.

You see the study team once more about 6 weeks after your surgery. This will be at the same time as your routine appointment after surgery.

Side effects

As AZD2014 is a new drug, there may be side effects we don’t know about yet. In other trials so far, the most common side effects have included

Tiredness (fatigue)
Feeling or being sick
Weight loss or loss of appetite
Diarrhoea or constipation
Dry skin or rash
Cough or shortness of breath
Dry or sore mouth
A drop in the number of white and red blood cells causing an increased risk of infection and tiredness and breathlessness
An increase in your blood sugar
A drop in the amount of potassium in your blood
Changes to the way your liver works
An effect on your heart – the study team will monitor this closely and it is important to let them know if you have chest pain, breathlessness or swollen ankles

You mustn’t eat certain foods during the study as they can affect how AZD2014 works. This includes grapefruit and Seville oranges. There are also some drugs that you mustn’t take at the same time as AZD2014. The study team can advise you about this.

You mustn’t use sunbeds or tanning booths during the study and for 3 months afterwards. If you go out in the sun during this time, you must wear sunglasses and use sunscreen.

Recruitment start:

02/10/2014

Recruitment end:

31/12/2016

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.

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Questions to ask your doctor about clinical trials

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

Chief Investigator

Dr Simon Pacey

Supported by

AstraZeneca
Cambridge University Hospitals NHS Foundation Trust
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University of Cambridge

Freephone 0808 800 4040

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