This is a
phase 3 trial. Researchers hope that about 720 people worldwide and 25 people from the UK will agree to take part.
It is a
randomised trial. The people taking part are put into 1 of the following treatment groups by computer:
- abiraterone and olaparib
- abiraterone and a dummy drug
Neither you nor your doctor can choose which treatment you are having. And neither you nor your doctor will know which treatment you are having. This is a
double blind trial.
Abiraterone
You take abiraterone tablets once, every day. You
swallow the tablets whole with a glass of water. Take them at least one hour before food, or at least 2 hours after eating.
You also take a steroid tablet once or twice a day. This is to help reduce some of the side effects.
Olaparib or dummy drug
Olaparib and the dummy drug come as tablets that you swallow whole, twice a day. You can take olaparib or the dummy drug with or without food.
Blood tests
You have extra blood tests as part of this trial. Researchers want to look for:
- certain proteins (biomarkers) that can tell how well treatment is working
- genes that can affect how we grow and develop
You have the extra blood tests before the start of treatment, at set times during the trial and when you finish treatment.
Tissue sample
Doctors ask to use a tissue sample of cancer they took during a biopsy or surgery (archival tissue sample). You need to give a new tissue sample if there isn’t a suitable sample available.
Doctors want to look at the genes that are involved in the process of repairing damaged cells.
Quality of life
- every 4 weeks for a year
- then every 8 weeks for as long as you take part in this trial
The questionnaires ask about how you have been feeling and what side effects you have had.
You also complete a questionnaire about pain and whether you have taken painkillers. You complete the pain questionnaire every day, for a week before you start treatment. You then complete the pain questionnaire every 4 weeks.
You complete all questionnaires on a handheld computer (tablet).