A trial looking at olaparib and degarelix for men with prostate cancer (CaNCaP03)
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 1
This trial is looking at the effect of having olaparib and degarelix before surgery to remove prostate cancer (radical prostatectomy).
It is for men who are going to have surgery for prostate cancer that hasn’t spread outside the prostate gland.
More about this trial
Surgery to remove the prostate gland is one of the main treatments for prostate cancer (radical prostatectomy). But sometimes prostate cancer comes back after surgery. This is a relapse 
.
. Doctors are looking for ways to stop prostate cancer from coming back after surgery. In this trial, they are looking at olaparib and degarelix.
Olaparib (Lynparza) is a targeted cancer drug called a PARP-1 inhibitor. It blocks the PARP-1 enzyme , which helps damaged cells to repair themselves. Doctors think that if they stop PARP-1 working, the cancer cells will not be able to repair themselves.
, which helps damaged cells to repair themselves. Doctors think that if they stop PARP-1 working, the cancer cells will not be able to repair themselves. Degarelix (Firmagon) is a hormone therapy drug. It works by stopping the body from making the hormone testosterone . Prostate cancer cells depend on this hormone to grow.
. Prostate cancer cells depend on this hormone to grow. Everyone taking part in this trial has 1 of the following:
- olaparib for 2 weeks
- degarelix and then olaparib for 2 weeks
After olaparib, or olaparib and degarelix, everyone has surgery to remove the prostate gland.
The main aims of this trial are to:
- see how olaparib and degarelix work on prostate cancer cells
- learn more about the side effects of olaparib and degarelix
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 you are a man and all of the following apply. You:
- have prostate cancer and doctors think surgery to remove the prostate gland (radical prostatectomy) is the best treatment for you
- have a cancer that has a high or intermediate risk of growing or spreading. Your doctor can tell you more about this
- are willing to have a sample of tissue taken (a biopsy) if there isn’t a suitable sample available (archival tumour sample)
- have satisfactory blood tests results
- have had a
chest x-ray and it’s normal - have a normal amount of oxygen in the blood (oxygen saturation)
- have no heart problems
- can swallow and absorb tablets
- are well enough to carry out your normal activities, apart from heavy physical work (performance status of 0 or 1)
- are at least 18 years old
- are willing to use reliable contraception during treatment and for 3 months afterwards if there is any possibility your partner could become pregnant
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
- have a condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukaemia (AML)
- have another cancer unless you have had treatment and there are no signs of the cancer coming back
- have moderate or severe side effects from previous anti cancer treatment, apart from hair loss
Medical conditions
You:
- have had an experimental treatment as part of another clinical trial in the last 3 months
- take drugs that affect some enzymes called CYP3A4, or the way your heart works. Your doctor can tell you more about this
- can’t take olaparib or degarelix for any reason
- are sensitive to olaparib, degarelix or anything it contains
- have a problem with your
digestive system that affects how you absorb tablets - have had
pneumonitis or any other major lung problem - have
spinal cord compression that isn’t controlled - have heart problems such as an irregular heartbeat (arrhythmia) or you have had a heart attack in the past 3 months
- have a blockage in a large vein called superior vena cava
- have had a major surgery in the past month, or a small operation in the last 2 weeks, and you still have side effects from it
- have an infection that needs treatment
- have had a blood transfusion in the past month
- have hepatitis B or hepatitis C
- have HIV
- have any other serious medical condition that the trial team thinks could affect you taking part
Trial design
This is a phase 1 trial. The researchers hope that around 20 men from the UK will take part.
This trial is randomised. Men are put into 1 of the following treatment groups by computer:
- olaparib (group A)
- degarelix and olaparib (group B)
Neither you nor your doctor are able to decide which group you are in.
Olaparib are tablets you take at home every day, twice a day. You swallow them whole, with or without food.
You have olaparib for about 2 weeks, until the morning of your operation.
Degarelix comes as an injection that you have under the skin (subcutaneously). You have it on the 1st day of olaparib if you are in group B.
Then everyone has surgery (radical prostatectomy). This is the same as the standard treatment. Your doctor can tell you more about this.
Diary
The trial team will give you a diary to complete at home. They will ask you to keep a record of when you take the tablets.
You return the diary to the team on the day of the surgery.
Blood tests
You have extra blood tests as part of this trial. Researchers want to learn more about what happens to olaparib and degarelix in your body and how it affects you.
You have the extra blood tests before the start of treatment and then:
- a week after the start of olaparib
- on the day of surgery
- 6 weeks after surgery
Urine sample
The trial team might also ask you to give a urine sample before the start of treatment, and a week after starting olaparib.
Tissue sample
The trial team will ask to use a tissue sample of your cancer that was taken when you were diagnosed. You may need to give a new sample (biopsy) if there isn’t a suitable sample available.
The team will also ask for a tissue sample taken during surgery. They want to look for any changes that may have been caused by olaparib or degarelix.
Hospital visits
You see a doctor and have some tests before taking part. These tests might include:
- physical examination
- blood tests
- urine test
- heart trace (
ECG ) - chest x-ray
People in Group B go to hospital to have degarelix and collect olaparib tablets.
The trial team can send you olaparib in the post, if you are in group A.
After 7 days of taking olaparib, you go back to hospital and have the same tests you had before the start of treatment.
You take olaparib for around 2 weeks and stop it on the morning of your operation.
You then see the trial doctor 6 weeks after surgery.
Side effects
The trial team monitor you while you are having treatment. They will give you 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 the trial.
The most common side effects of olaparib are:
• indigestion
• tiredness (fatigue)
• headaches and feeling dizzy
• a drop in the number of white and red blood cells causing an increased risk of shortness of breath, tiredness and infection
• high levels of creatinine in the blood
The most common side effects of degarelix are:
• pain and redness at the injection site
We have more information about the side effects of olaparib and degarelix. And information about surgery for prostate cancer.
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
Dr Simon Pacey
Supported by
AstraZeneca
Cambridge Cancer Trials Centre
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
Last review date
CRUK internal database number:
14899
Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.
