A study looking at carboplatin in prostate cancer with genetic changes (BARCODE 2)
Cancer type:
Status:
Phase:
This study is for men with prostate cancer who are having, or have had, treatment with docetaxel and an 
.
More about this trial
The usual treatment for prostate cancer that has spread to another part of the body (advanced prostate cancer) includes:
- docetaxel (Taxotere)
- hormone therapy called an anti androgen (such as abiraterone or enzalutamide)
But doctors are always looking for new ways to control advanced prostate cancer.
Changes to are thought to play a role in the development of prostate cancer. Doctors think certain chemotherapy drugs might work better in people with certain genetic changes.
There are 2 parts in this study.
Part 1 involves testing for gene changes (mutations). You have a blood test for this.
Part 2 is for men who have a genetic change (mutation). In this part of the study you have treatment with a chemotherapy drug called carboplatin.
This study aims to find out if carboplatin helps to control prostate cancer in men with genetic changes.
Who can enter
The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.
You may be able to join this study if all of the following apply. You:
- have adenocarcinoma of the prostate that has spread to another part of your body
- have cancer that has continued to grow despite treatment to block your hormones (either hormone therapy with a type of drug called a luteinising hormone or an orchidectomy)
- are having or have had docetaxel and an anti androgen or cabazitaxel
- have satisfactory blood results
- are well enough to be up and about for at least half the day (performance status 0,1 or 2)
- are at least 18 years old
For part 2, all of the following must also apply. You:
- have a confirmed gene change (mutation)
- have cancer that has come back or continued to grow after docetaxel and an anti androgen or cabazitaxel
- are willing to use reliable contraception throughout the time you have carboplatin and for 6 months after the last dose
You cannot join this study if any of these apply. You:
- have had a recent scan showing cancer spread in a vital organ (such as your spinal cord). You might be able to join if the cancer has spread to your brain and it has been successfully treated and there are no symptoms
- have a tumour that is bleeding
- have had treatment with a
platinum based chemotherapy for prostate cancer - have had treatment with a targeted cancer drug called a PARP inhibitor (biological therapy)
- have had an allergic reaction to carboplatin or other platinum drug
- have had the yellow fever vaccine in the last 6 months
- are not well enough to have chemotherapy
- have ongoing moderate to severe damage to your nerves (neuropathy)
- have or have had another cancer that your doctor thinks will affect you taking part in this trial
- have a hearing impairment
- have had serious heart problems such as a heart attack or unstable angina in the last 6 months
- have had a stroke in the last 2 years (part 2 of the study only)
Trial design
This is a phase 2 study. It is in 2 parts.
Part 1
The researchers need about 450 men to join part 1. Everyone has a blood test. This is to look for genetic changes (mutations).
If you do not have a genetic change (mutation) your part in the study will end.
Part 2
If you are found to have one of the genetic mutations associated with prostate cancer you might be able to join part 2. The study team expect 24 to 40 men to be suitable to join part 2.
You have carboplatin through a drip into a vein once every 3 weeks. Each 3 week period is called a cycle of treatment. To start off with you have 2 cycles of treatment. You then have a scan to see how well the treatment is working.
You can have up to 10 cycles of treatment, as long as it is controlling your prostate cancer and your side effects are not too bad.
Blood and urine samples for research
At each visit you will be asked for a blood and urine sample for research. The samples are studied in the laboratory. They help doctors understand how the treatment affects your prostate cancer.
You do not need to give these samples if you do not want to. You can still take part in the study.
Hospital visits
Before taking part in this study you see a doctor and might have some of the following tests:
- physical examination
- heart trace test (
ECG ) - CT scan
- bone scan
- blood tests (including
prostate specific antigen ) - urine tests
At every visit you see a doctor to talk about how you are and any side effects. You have blood tests at each visit.
You have a CT scan and a bone scan after every 2 to 3 cycles of carboplatin. This is to see how well it is working.
Side effects
The most common side effects of carboplatin are:
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- feeling or being sick
- changes to how your kidneys work
- loss of fertility
We have more information about the side effects of carboplatin.
Location
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.
Chief Investigator
Professor Ros Eeles
Supported by
European Research Council (ERC)
Institute of Cancer Research (ICR)
The Royal Marsden NHS Foundation Trust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
