"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial comparing olaparib with enzalutamide or abiraterone for men with prostate cancer (PROfound)
This trial compared olaparib with enzalutamide or abiraterone for men with prostate cancer that had spread to other parts of the body.
It was for men who’d:
- had surgery to remove the testicles (orchidectomy) or were having treatment with hormone therapy
- had changes in genes called homologous recombination repair (HRR)
This trial was open for people to join between May and September 2018. The results were published in a journal in 2020 and on the pharmacy company’s website in 2021.
More about this trial
- surgery to remove the testicles (orchidectomy)
- hormone therapy to reduce the level of testosterone in your body
You usually have hormone therapy such as enzalutamide and abiraterone for castration resistant prostate cancer. But doctors are looking for new ways to help men in this situation. In this trial, they looked at olaparib.
This trial was in 2 parts. First, doctors tested a sample of your cancer for changes (
Everyone joining the 2nd part of this trial had one of the following:
- olaparib (Lynprza)
- enzalutamide or abiraterone
Enzalutamide and abiraterone are 2 types of
The main aim of this trial was to find out whether olaparib was better than enzalutamide and abiraterone for men with castration resistant prostate cancer.
Summary of results
The team found that men with advanced prostate cancer who had olaparib lived longer before their cancer got worse.
About this trial
This was a phase 3 trial. It was a
Of the 387 people who took part:
- 245 had olaparib
- 142 had either abiraterone or enzalutamide
The team looked at how long it took for the cancer to get worse. They found that the
- just under 7½ months (7.4 months) for those who had olaparib
- just over 3½ months (3.6 months) for those who had enzalutamide or abiraterone
They also looked at the how long people lived after treatment. They found that the median time was:
- 17½ months for those who had olaparib
- just over 14 months (14.3 Months) for those who had enzalutamide or abiraterone
Quality of life
After a year of treatment the team looked at pain. They wanted to know the number of people whose pain had not got worse. They found it was:
- about 76 people out of every 100 (76½%) for those who had olaparib
- about 43 people out of every 100 (43.1%) for those who had enzalutamide or abiraterone
There were more severe side effects with olaparib than with either enzalutamide or abiraterone.
The most common side effects overall for olaparib were:
- a drop in blood cells causing tiredness, increase of infection, bruising and bleeding
- feeling or being sick
- tiredness and lack of energy (fatigue)
- feeling weak
- loss of appetite
- changes in taste
- diarrhoea or constipation
- indigestion and heartburn
- inflammation of the mouth and lips
- loss of weight
- swelling of the arms and legs
The most common side effects overall for enzalutamide or abiraterone were:
- tiredness (fatigue)
- lack of energy
- feeling weak
The trial team concluded that olaparib worked better than enzalutamide or abiraterone for men:
- with prostate spread that had continued to grow despite hormone treatment
- and had changes (mutations) in the HRR genes
When compared with enzalutamide and abiraterone, olaparib:
- stopped the cancer getting worse for a longer time
- was better for and more accepted by the patients
Researchers are looking at olaparib in further trials.
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 (
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.
Professor Johann de Bono