A trial of capivasertib with docetaxel for prostate cancer that has spread (ProCAID)

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 2

This trial looked at adding a drug called capivasertib to chemotherapy to see how well it worked for prostate cancer. 

It was for men whose cancer:

  • had spread to another part of the body (advanced cancer)
  • wasn’t responding to hormone therapy Open a glossary item

The trial was supported by Cancer Research UK.

This trial was open for people to join between 2015 and 2019. The team published the results in 2020.

More about this trial

You might have hormone therapy for prostate cancer that has spread elsewhere in the body. This controls the cancer for some time but it may come back after a while. You may then have a chemotherapy drug called docetaxel and a steroid called prednisolone Open a glossary item.

Researchers are looking for ways to improve treatment for advanced prostate cancer. In this trial they looked at a drug called capivasertib (AZD5363).  

Capivasertib is a targeted drug Open a glossary item called a cancer growth blocker. It stops signals that cancers use to divide and grow. Researchers thought that having capivasertib with chemotherapy would help to control the cancer for longer. 

In this trial some people had docetaxel, prednisolone and capivasertib. And some had docetaxel, prednisolone and a dummy drug (placebo Open a glossary item).

The main aims of the trial were to:

  • see if having capivasertib alongside chemotherapy works better than chemotherapy on its own 
  • learn more about the side effects

Summary of results

The trial team didn’t find that adding capivasertib improved treatment. It didn’t increase the length of time before the cancer started to grow again. But the side effects were manageable. 

Trial design
150 people took part in this phase 2 trial

There were 2 treatment groups. People were put into a group at random:

  • 75 had docetaxel, prednisolone and capivasertib
  • 75 had docetaxel, prednisolone and a dummy drug 

Neither the men nor their doctor could choose which group they were in. And neither of them knew which group they were in. This is called a double blind trial.

Everyone had treatment in cycles. Each 3 week period was a cycle of treatment Open a glossary item. They had:

  • docetaxel and prednisolone for up to 10 cycles
  • capivasertib or the dummy drug for as long as treatment was working and the side effects weren’t too bad

Results
The trial team looked to see how well treatment worked. They looked at how long it was before the cancer started to grow again. This is called progression free survival. They found it was:

  • just over 7 months (7.03) for people who had docetaxel, prednisolone and capivasertib
  • just under 7 months (6.7) for people who had docetaxel, prednisolone and the dummy drug 

So the team found that adding capivasertib didn’t increase the length of time before the cancer started to grow again. 

The trial team also looked at how long people lived. They found that this was about:

  • 31 months for the people who had docetaxel, prednisolone and capivasertib
  • 20 months for the people who had docetaxel, prednisolone and the dummy drug 

So the trial found that people in the capivasertib group lived about 11 months longer. This isn’t what the team had expected. They aren’t sure why people who had capivasertib lead to an increase in the time people lived. But it didn’t extend the length of time before the cancer started to grow again.  

The team say the data from the trial doesn’t provide a clear explanation for why this happened. They think it is possible that these results may be false. There might have been some bias Open a glossary item within the trial design that they weren’t fully aware of. 

Some differences between the people in each group may have favoured the capivasertib group. There may have been a number of reasons for this. For example people in the capivasertib group may have had lower rates of cancer spread in the liver or lung. 

Tissue and blood samples 
The trial team looked at the blood and tissue samples (biopsies Open a glossary item) the men gave as part of their routine diagnosis. They wanted to see if their cancer cells had changes (mutations) Open a glossary item in any of the following genes:

  • PIK3CA
  • AKT1
  • PTEN

The team had this information for 136 people. Of those:

  • 44 had the gene changes
  • 92 didn’t have the gene changes

The team thought that capivasertib would work better in those who had the gene changes. But the team found no link between this and how well treatment worked in either group. 

Side effects
The team looked at the number of bad to severe side effects. There were a similar number in both treatment groups. 

The most common related to capivasertib were:

  • diarrhoea
  • tiredness (fatigue)
  • feeling sick
  • skin rash

The team found the side effects were manageable. 

Conclusion
The trial team concluded that adding capivasertib to chemotherapy didn’t work for people with advanced prostate cancer. It didn’t increase the length of time before the cancer started to grow again. 

Adding capivasertib increased how long people lived. But it is possible that bias may have impacted these results. 

Even so, all trial results help doctors and researchers understand more about different cancers and the best way to treat them. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

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 Crabb

Supported by

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

Other information

This is Cancer Research UK trial number CRUK/12/042.

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10556

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:

Rate this page:

Currently rated: 5 out of 5 based on 3 votes
Thank you!
We've recently made some changes to the site, tell us what you think