ProCAID

• Research type

  Research Study

• Full title

  An open label phase I/randomised, double-blind phase II study in metastatic castration resistant Prostate Cancer of AZD5363 in combination with Docetaxel and prednisolone chemotherapy (ProCAID)

• IRAS ID

  135504

• Contact name

  Simon Crabb

• Contact email

  S.J.Crabb@southampton.ac.uk

• Sponsor organisation

  University Hospitals Southampton NHS Foundation Trust

• Eudract number

  2013-002391-41

• ISRCTN Number

  n/a

• Research summary

  Research Summary:
  There was no research summary available.

  Lay summary of study results: 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.

  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.
  

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  13/LO/1691

• Date of REC Opinion

  30 Dec 2013

• REC opinion

  Further Information Favourable Opinion