A trial of AZD5363 with docetaxel and prednisolone for prostate cancer that has spread and is no longer responding to hormone therapy (ProCAID)

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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 a drug called AZD5363 alongside chemotherapy to see if it helps men with prostate cancer that has spread to another part of the body and isn’t responding to hormone therapy.

The trial is supported by Cancer Research UK.

More about this trial

If prostate cancer spreads to other parts of the body, doctors often treat it with hormone therapy. But after a while, this can stop working. If this happens, you may have chemotherapy and steroids. But researchers are looking for new treatments to help men in this situation. In this trial they are looking at a drug called AZD5363 alongside chemotherapy and steroids.

AZD5363 is a type of biological therapy. It stops signals that cancer cells use to divide and grow.

The aims of the trial are to

Find the highest dose of AZD5363 that you can have safely alongside docetaxel chemotherapy and a steroid called prednisolone
See if having AZD5363 with chemotherapy and steroids helps men with prostate cancer more than a dummy drug (placebo )
Learn more about the side effects

Who can enter

You may be able to enter this trial if you

Have prostate cancer that has spread to another part of your body, is not responding to hormone therapy and PSA tests, a CT scan or a bone scan show that your cancer is getting worse
Are going to have docetaxel chemotherapy
Have very low levels of the hormone testosterone
Have stopped any other prostate cancer treatment at least 2 weeks ago (you can take part if you’re having hormone therapy to keep your testosterone level low)
Have cancer that didn’t get smaller within 6 weeks of stopping the drugs bicalutamide or flutamide
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
Your heart is working well enough - your doctor will check for this
Are able to swallow tablets
Are at least 18 years old
Are willing to use reliable contraception during the trial and for a month afterwards if there is any chance your partner could become pregnant

You cannot enter this trial if you

Have already had chemotherapy for prostate cancer (you may have had other drugs such as bisphosphonates, denosumab, abiraterone, enzalutamide or up to 6 treatment cycles of docetaxel)
Have cancer that has spread to your brain or caused spinal cord compression unless this was treated successfully
Have had radiotherapy to more than about a third of your bone marrow (your doctor can advise you about this)
Have had another experimental drug in the last month
Have had any other type of cancer if your doctor thinks there is a 30% or more chance of it coming back within 2 years
Have type 1 or type 2 diabetes that requires medication (you may be able to take part if you have type 2 diabetes - your doctor will check this)
Have a problem with your digestive system that means it may be difficult for you to absorb the trial drug
Have had a heart attack in the last 6 months or have certain other heart problems (the trial team can advise you about this)
Have low blood pressure that can’t be controlled with medication
Have protein in your urine
Have taken other medication that affects body substances called cytochrome P (CYP) enzymes in the last 2 weeks (the trial team can advise you about this)
Have taken St John’s wort in the last 3 weeks
Haven’t recovered from the side effects of other treatment (apart from hair loss) unless they are very mild
Are known to be very sensitive to AZD5363 or similar drugs
Have already had drugs that target proteins called AKT, PI3K or mTOR (your doctor can advise you about this)

Trial design

This phase 1/2 trial will recruit about 150 men. The trial is in 2 parts.

In part 1, the researchers are looking for the highest dose of AZD5363 that you can safely have with docetaxel and prednisolone. In this part of the trial, everybody has AZD5363. The first few men taking part will have a low dose of AZD5363. If they don’t have any serious side effects, the next few patients will have a higher dose. And so on, until they find the best dose to give. This is called a dose escalation study.

Please note - this part of the trial has finished and patients are now being recruited to part 2.

In part 2, they are comparing AZD5363 with a dummy drug (placebo Open a glossary item ). This part of the trial is randomised. The men taking part are put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

Everybody joining this part of the trial has docetaxel and prednisolone. Half the men also have the highest safe dose of AZD5363 that was found in part 1. The other half will have a dummy drug.

ProCAID trail diagram

In both parts of the trial you have chemotherapy in 3 week periods called cycles of treatment. You have up to 10 cycles of chemotherapy.

You have docetaxel through a drip into a vein on the 1st day of each treatment cycle. It takes about an hour each time. You take prednisolone tablets every day.

You take AZD5363 (or the dummy drug) throughout your treatment, starting on the 2nd day of the 1st cycle of chemotherapy. AZD5363 comes as tablets that you swallow. You take the tablets twice a day for 4 days, followed by a 3 day break.

You should take the tablets 12 hours apart and try to take them at about the same time each day. You mustn’t eat or drink anything apart from water for at least 2 hours before taking the tablets and for at least 1 hour afterwards.

If they are helping you, you can carry on taking the tablets after you finish having chemotherapy, as long as you don’t have bad side effects.

The trial team will give you a diary to help you to remember the days when you need to take the tablets.

They will also ask you to complete a questionnaire a number of times during the trial and when you finish treatment. It will ask about any pain you have, how it is being managed and how it is affecting your daily activities.

Hospital visits

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

Physical examination
Heart trace (ECG )
Heart scan (echocardiogram or MUGA)
Blood tests
CT scan or MRI scan
Bone scan

If you join phase 1 of the trial, you go to hospital 5 times in each of the first 2 cycles of treatment. You have a number of blood tests at these visits. On some days, the trial team will ask you not to eat anything for 8 hours before arriving at the hospital and not to take your capsules until you’ve had a blood test.

From cycle 3 onwards, you go to hospital at least once every 3 weeks for as long as you have the trial treatment.

If you join phase 2, you go to hospital twice in the 1st cycle of treatment and then once every 3 weeks after that.

Everybody has regular blood tests and some more heart traces throughout the trial. The trial team will explain what will happen at each hospital visit.

When you finish treatment, you see the trial team and have more blood tests and scans. You then continue to see them every 6 weeks until your cancer starts to get worse or you start another type of treatment.

Side effects

As AZD5363 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 included

Diarrhoea
Feeling or being sick
Loss of appetite
Inflammation of the mouth and lips
An increase in your blood sugar level
Rash
Dry or itchy skin
Sore mouth
An allergic reaction causing symptoms such as a rash, itchiness, flushing, hives, itchy throat, high temperature (fever), swelling of the lips and, or face

The most common side effects of docetaxel include

A drop in blood cells causing an increased risk of infection, tiredness and breathlessness
Feeling sick
Sore mouth
Numbness and tingling in your hands and feet (peripheral neuropathy)
An allergic reaction
A rash
Fluid retention causing swollen ankles

The most common side effects of prednisolone include

Stomach discomfort
Fluid retention
An increase in your blood sugar level

Recruitment start:

29/01/2014

Recruitment end:

31/01/2019

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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Chief Investigator

Dr Simon Crabb

Supported by

AstraZeneca
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University Hospital Southampton NHS Foundation Trust