"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A study of rucaparib in advanced prostate cancer (TRITON3)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
- abiraterone
- enzalutamide
- docetaxel
More about this trial
- BRCA1 (breast cancer susceptibility gene 1)
- BRCA2 (breast cancer susceptibility gene 2)
- ATM (ataxia telangiectasia mutated serine gene)
- understand how rucaparib works when compared to standard treatments in advanced prostate cancer with a BRCA or ATM genetic change (mutation)
- look for substances called
biomarkers to find out which men with prostate cancer might benefit most from rucaparib - learn more about the side effects
- find out more about
quality of life
Who can enter
- have a type of prostate cancer called
adenocarcinoma or prostate cancer cells that look very abnormal under a microscope (poorly differentiated - have a BRCA1 or BRCA2 gene change (mutation)
- have prostate cancer that has spread to other parts of your body (metastatic prostate cancer) and that got worse after treatment with hormonal treatments such as abiraterone or enzalutamide
- have had surgery to remove your testicles or have been taking drugs to lower the level of
testosterone in your body (luteinising hormone agonists such as goserelin or leuprorelin) - are eligible to receive treatment with a standard prostate cancer treatment (abiraterone, enzalutamide or docetaxel)
- have satisfactory blood test results
- are fit enough to carry out normal everyday activities apart from hard physical work (performance status 0 or 1)
- are willing to use contraception during treatment and for 6 months afterwards
- are aged 18 or over
- another type of cancer, apart from non melanoma skin cancer, a
carcinoma in situ , or superficial bladder cancer - had treatment for any type of cancer apart from prostate cancer in the last 6 months
- had a bone marrow transplant in the last 2 years
- had previous treatment with another PARP inhibitor
- had chemotherapy for prostate cancer after your prostate cancer spread to other parts of your body (metastatic prostate cancer)
- cancer that has spread to your brain or spinal cord and is causing symptoms
- cancer that is pressing on your spinal cord (
spinal cord compression ) - stents in your stomach or other problems that might affect how you absorb the drug
- HIV or AIDS or Hepatitis B or Hepatitis C
- had anti-cancer treatment in the last 14 days before starting study treatment, apart from LHRH analogs such as zoladex
- started or changed treatment for bone thinning (bisphosphonates or denosumab) in the last 28 days before starting study treatment
- had a minor operation in the last 5 days or a larger operation in the 21 days before starting study treatment
- have not recovered from the side effects of other cancer treatment unless they are mild, apart from hair loss
- have any other serious medical condition or mental health problem that the study team think could affect you taking part
Trial design
- enzalutamide
- abiraterone
- docetaxel
If you are having standard prostate cancer treatment and your cancer worsens, you may be able to start treatment with rucaparib. If this applies to you, your doctor will discuss it further with you.
Treatment with rucaparib
The trial drug rucaparib is a tablet. You take the tablets twice a day, everyday. You have treatment for as long as it is working and the side effects aren’t too bad.
In some cases, you might continue treatment if your cancer gets worse and your doctor thinks this is in your best interest. But the study team can tell you more if this applies.
Standard treatment
Docetaxel is a chemotherapy drug. You have it through a drip into your vein (intravenously).
You have docetaxel in cycles of treatment. Each cycle is 3 weeks, and so you have treatment with docetaxel once every 3 weeks. You might have up to 10 cycles of treatment.
Enzalutamide is a capsule and abiraterone is a tablet. You have treatment with one or the other for as long as it is working and the side effects aren’t too bad.
In some cases, you might continue treatment if your cancer gets worse and your doctor thinks this is in your best interest. But the study team can tell you more if this applies.
Hospital visits
Before starting treatment you will see the doctor and you will have some tests. These tests might include:
- physical examination
- medical history
- blood tests
- urine sample testing (urinalysis)
- heart trace (
ECG ) - CT scan or MRI scan, and
bone scan
Treatment with rucaparib, enzalutamide and abiraterone
You see the doctor about every 2 weeks for the first 2 months, and then once a month after that. At each visit you will have tests and procedures performed, including the following:
- a physical examination
- blood tests
- urine sample tests (urinalysis)
You will have scans every 2 to 3 months after you start study treatment.
Treatment with docetaxel
You see the doctor about every 3 to 4 weeks for up to approximately 10 cycles. At each visit you will have tests and procedures performed, including the following:
- a physical examination
- blood tests
- urine sample tests (urinalysis)
You will have scans every 2 to 3 months after you start study treatment.
Side effects
- feeling or being sick
- tiredness (fatigue)
- taste changes
- loss of appetite
- changes in blood test results that measure how your liver and kidneys are working
- a drop in blood cells causing an increased risk of infection, bleeding problems, tiredness and breathlessness
- constipation or diarrhoea
- increased fat (cholesterol) levels in the blood
- dizziness
- difficulty breathing
- stomach pain
- sensitivity to sunlight causing itchy or inflamed skin – the study team advise you to avoid long periods in the sun, wear protective clothing and use sunscreen
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
Dr Elias Pintus
Supported by
Clovis Oncology, Inc
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040