A trial of custirsen with cabazitaxel and prednisolone for prostate cancer that has spread (AFFINITY)

Coronavirus (COVID-19)

We know that this is an especially worrying time for people with cancer and their family and friends. We have separate information about coronavirus and cancer. Please read that information alongside this page. We will update that information as guidance changes.

Read about coronavirus and cancer

Cancer type:

Prostate cancer

Status:

Results

Phase:

Phase 3

This trial looked at custirsen with cabazitaxel and prednisolone for men who had prostate cancer that had spread and other treatments were no longer working.

More about this trial

Cabazitaxel is a chemotherapy drug that doctors sometimes use to treat prostate cancer. In this trial, researchers looked at a type of targeted cancer drug called custirsen (OGX-011) with cabazitaxel and a steroid called prednisolone.

The men who took part in this trial had prostate cancer that had spread, and had got worse despite having hormone therapy and docetaxel chemotherapy.

The aim of the trial was to see if the combination of custirsen, cabazitaxel and prednisolone is a useful treatment for men in this situation.

Summary of results

This trial showed that custirsen, cabazitaxel and prednisolone was not better than cabazitaxel and prednisolone for prostate cancer that had spread.

Results
This trial recruited over 600 men with prostate cancer. They were put into 1 of 2 treatment groups at random, and:

  • half had custirsen, cabazitaxel and prednisolone
  • half had cabazitaxel and prednisolone

In 2016 the research team analysed the results to find out how well the treatments worked. They looked at how many people had died so far and found it was similar in both groups:

  • 263 out of 317 men (83%) who’d had custirsen, cabazitaxel and prednisolone
  • 267 out of 318 men (84%) who’d had cabazitaxel and prednisolone

They looked at how long the men taking part lived for, and found that was also similar in both groups:

  • 14.1 months for those who had custirsen, cabazitaxel and prednisolone
  • 13.4 months for those who had cabazitaxel and prednisolone

Side effects
More than 9 out of 10 men taking part had side effects, but some were mild or short lived. Some had side effects that were more serious:

  • 155 out of 315 men (49%) who had custirsen, cabazitaxel and prednisolone
  • 132 out of 312 men (42%) who had cabazitaxel and prednisolone

The most common side effects were a drop in white blood cells and red blood cells, tiredness or lack of energy and bone plain.

Conclusion
The research team concluded that custirsen did not help men with prostate cancer that had spread live longer. They suggest that cabazitaxel and prednisolone is used for men who have already had hormone therapy and docetaxel chemotherapy.

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

Karim Fizazi
Tomasz Beer
Sebastien Hotte

Supported by

Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
OncoGenex Pharmaceuticals, Inc

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10725

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:

No votes yet
Thank you!
We've recently made some changes to the site, tell us what you think