A trial looking at cabazitaxel for prostate cancer that has started to get worse after having hormone therapy and docetaxel (CANTATA)

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 2

This trial is comparing the chemotherapy drugs cabazitaxel and docetaxel for prostate cancer that has spread to other parts of the body. The men taking part have prostate cancer that has started to get worse after having both hormone therapy and docetaxel. The trial is supported by Cancer Research UK.

More about this trial

If prostate cancer has spread outside the prostate gland, doctors often treat it with hormone therapy. This can work very well, but at some stage the cancer may start to grow again.

Doctors can treat prostate cancer that is no longer responding to hormone therapy with chemotherapy. Docetaxel is a chemotherapy drug they often use. If prostate cancer comes back after having docetaxel, you may have the drug again. Doctors call this a re-challenge.

Cabazitaxel is another chemotherapy drug that doctors can use for men with prostate cancer who have had hormone treatment and docetaxel.

In this trial, researchers are comparing cabazitaxel and a docetaxel re-challenge for prostate cancer that has spread and is now getting worse after having hormone therapy and docetaxel.

Many of the men taking part have had docetaxel at the same time as hormone therapy in another prostate cancer trial called STAMPEDE. But other men who have had docetaxel for prostate cancer that is no longer responding to hormone therapy may also be able to take part.

The aims of the trial are to

  • See which treatment helps men more
  • Learn more about the side effects

Who can enter

You may be able to enter this trial if you

  • Have prostate cancer that has stopped responding to hormone therapy
  • Have had up to 6 cycles of docetaxel, either in the STAMPEDE trial, or outside of the trial if you started it within 3 months of starting hormone therapy
  • Have cancer that has spread to other parts of your body and blood tests, symptoms or scans show your cancer is now getting worse
  • Are well enough to be up and about for at least half the day (performance status 0, 1 or 2)
  • Have satisfactory blood test results
  • Are at least 18 years old
  • Are willing to use reliable contraception if there is any chance your partner could become pregnant

You cannot enter this trial if you

Trial design

This phase 2 trial will recruit 138 men. It is a randomised trial. The men taking part are put into treatment groups by a computer. Neither you nor your doctor can decide which group you are in.

  • Men in one group have cabazitaxel through a drip into a vein every 3 weeks
  • Men in the other group have docetaxel through a drip into a vein every 3 weeks

CANTATA trial diagram

You can have treatment up to 10 times, lasting up to 30 weeks all together.

Men in both groups also take a steroid tablet called prednisolone every day throughout their treatment.

The trial team will ask you to fill out a questionnaire before you start treatment, after you finish treatment and then every 3 months for up to 2 years. The questionnaire will ask about side effects and how you’ve been feeling.  This is called a quality of life study.

The quality of life study is optional. You don’t have to fill out these questionnaires if you don’t want to. You can still take part in the trial.

The trial team will also ask your permission to get samples of your cancer from when you had surgery or biopsies. They will use these samples for future research.

Hospital visits

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

  • Physical examination
  • Blood tests
  • Chest X-ray

You may need to have a bone scan and a CT or MRI scan, but only if you haven’t had these done in the last 6 weeks.

You go to hospital for treatment every 3 weeks. When you finish treatment, you see the trial team again a month later and then once every 3 months for up to 2 years.

Side effects

The most common side effects of docetaxel include

The most common side effects of cabazitaxel include

  • High temperature (fever)
  • Feeling or being sick
  • Sore mouth
  • Taste changes
  • Shortness of breath
  • Diarrhoea
  • Tiredness (fatigue)
  • Hair loss
  • Pain in your muscles, joints or back
  • A drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
  • Blood in your urine

We have more information about docetaxel and cabazitaxel in our cancer drugs section.

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

Professor Nick James

Supported by

Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
Sanofi
University of Birmingham

Other information

This is Cancer Research UK trial number CRUKE/12/031.

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10087

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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