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

Cancer type:

Prostate cancer




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 Open a glossary item)

Who can enter

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

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 Open a glossary item 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 Open a glossary item). 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 Open a glossary item)
  • Heart scan (echocardiogram Open a glossary item)
  • 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

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:

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

Dr Simon Pacey

Supported by

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

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:


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

Keith took part in a trial looking into hormone therapy

A picture of Keith

"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”

Last reviewed:

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