A trial looking at olaparib and abiraterone for prostate cancer (PROpel)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Secondary cancers

Status:

Closed

Phase:

Phase 3

This trial is for people with metastatic castration resistant prostate cancer (mCRPC). This means that the cancer:

has spread to other parts of the body
got worse despite having hormone treatment

It is for people who are going to have treatment for metastatic resistant prostate cancer for the first time.

More about this trial

Hormone therapy and chemotherapy are possible treatments for prostate cancer. These can work well for a period of time. But the cancer can spread to other parts of the body or start to grow again. This is metastatic castration resistant prostate cancer.

Abiraterone is a type of hormone therapy that stops the testicles from making testosterone. It is already a possible treatment for people with prostate cancer that has spread to other parts of the body.

Olaparib is a type of targeted drug called a cancer growth blocker. It stops cancer cells from dividing and growing. Olaparib is already a possible treatment for people with ovarian cancer.

Everyone taking part in this trial has 1 of the following treatments:

abiraterone and olaparib
abiraterone and a dummy drug (placebo)

The main aim of this trial is to find out how well abiraterone and olaparib work for people with metastatic castration resistant prostate cancer.

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this trial if all of the following apply:

you have a type of prostate cancer called adenocarcinoma
your cancer has spread to other parts of the body (metastatic) and got worse despite having hormone treatment (castration resistant)
you are going to have treatment for metastatic castration resistant prostate cancer for the first time
you have had surgery to remove the testicles or you have been taking drugs to lower the amount of testosterone in your body
doctors think that abiraterone is a suitable treatment for you
you have satisfactory blood test results
there is a tissue sample of your cancer available from a biopsy or surgery (or you are willing to have a new sample taken)
you are well enough to carry out your normal activities apart from heavy physical work (performance status 0 or 1)
you are willing to use reliable contraception during treatment and for 3 months afterwards if there is any possibility your partner could become pregnant
you can swallow and absorb tablets
you are aged 18 or over

Who can’t take part

You cannot join this trial if any of these apply.

Cancer related

You:

have cancer spread in your brain (brain metastases)
have spinal cord compression unless you have had treatments and it has been stable for 4 weeks
have moderate or severe side effects from previous cancer treatment apart from hair loss
have had olaparib, abiraterone or any other similar drug
have had chemotherapy or radiotherapy in the past 3 weeks (1 week if it was radiotherapy to help with symptoms)
have a blood disorder called myelodysplastic syndrome (MDS) or acute myeloid leukaemia (AML)
have had another cancer in the past 5 years apart from non melanoma skin cancer that has been successfully treated

Medical conditions

You cannot join this trial if any of these apply. You:

have side effects from major surgery that you had in the last 2 weeks
have heart problems such as high blood pressure, angina that isn’t stable, an irregular heart rhythm, or you have had a heart attack in the past 6 months
have had a stroke in the last 6 months
are going to have heart surgery or you have had surgery to widen narrowed or blocked blood vessels
have problems with your pituitary gland or adrenal glands
have lung problems such as inflammation of the lung tissue (pneumonitis)
take, or have taken drugs from a group of medicines called CYP3A inhibitors and CYP3A inducers in the last 3 weeks
have an active infection
have HIV
have hepatitis B or hepatitis C
have had a bone marrow transplant from a donor
can’t take drugs that damp down your immune system (steroids) for any reason or you take a high dose of steroids every day (your doctor can tell you more about this)
are taking part, or have taken part in another clinical trial looking at a new drug or device in the past month
have any other medical condition or mental health problem that doctors think could affect you taking part

Other

You cannot join this trial if any of these apply. You:

are sensitive to olaparib, abiraterone or anything they contain
are involved in the planning or running of this trial

Trial design

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.

15962.png

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

Everybody taking part completes quality of life questionnaires before the start of treatment and then:

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).

Hospital visits

You see a doctor and have some tests before taking part. These tests might include:

physical examination
heart trace (electrocardiogram)
ultrasound scan of your heart (ECHO)
blood tests
a CT scan or MRI scan
bone scan

During treatment, you see the trial team every 2 weeks for the first three months. You then see them every month. You have blood tests and a physical examination every time you see them.

You have a CT scan or MRI scan every 8 weeks, for up to 6 weeks. You then have a CT scan or MRI scan every 3 months.

This continues for as long as the treatment is helping you and the side effects aren’t too bad. You stop treatment if your cancer gets worse.

When you finish treatment, you see the trial team after a month. You then see or speak with the trial team every 3 months.

Side effects

The trial team monitor you during treatment and afterwards. You have a phone number to call them if you are worried about anything. The team will tell you about all the possible side effects before you start treatment.

The most common side effects of olaparib are: