"Health wise I am feeling great. I am a big supporter of trials - it allows new treatments and drugs to be brought in.”
A trial looking at docetaxel and saracatinib for prostate cancer that has spread (SAPROCAN)
This trial is looking at docetaxel and saracatinib for prostate cancer that has continued to grow despite other treatment and has spread outside the prostate. This trial is supported by Cancer Research UK.
Doctors often treat prostate cancer that has spread with a chemotherapy drug called docetaxel (Taxotere). They hope that giving a new drug called saracatinib (also called AZD0530) as well as docetaxel will work better than docetaxel alone.
Saracatinib is a type of biological therapy called a tyrosine kinase inhibitor. Researchers hope that it will stop the cancer growing and spreading. But it is a new drug and they are not sure yet how well it work.
There is some evidence from other trials that saracatinib may also help with pain caused by prostate cancer that has spread. The people taking part in this trial will fill out questionnaires about their pain to help find out more about this.
The aims of this trial are to find out
- How well saracatinib works for prostate cancer that has spread
- If saracatinib helps with pain caused by prostate cancer that has spread
- More about the side effects
Who can enter
You may be able to enter this trial if you
- Have prostate cancer that has spread to another part of your body and continued to grow despite treatment
- Have a
testosteronelevel of less than 1.7 nanomoles per litre (nmol/l) – your doctor can tell you about this
- Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
- Have satisfactory blood test results
- Are able to swallow tablets
- Are prepared to use reliable contraception during the trial and for a month afterwards
- Are at least 18 years old
You cannot enter this trial if you
- Have prostate cancer that has spread to your brain or spinal cord, unless it has been successfully treated and you have no symptoms
- Have had chemotherapy for your prostate cancer already (you can still take part if you are having bisphosphonates such as zoledronate)
- Have had a reaction to a commonly used drug additive called cremaphor in the past
- Have had radionuclide treatment such as strontium for your prostate cancer
- Have had radiotherapy to more than a third of your bone marrow
- Have had treatment as part of another trial within the last month
- Have had anti androgen treatment such as flutamide or bicalutamide in the last 6 weeks
- Are taking any medicines that affect an enzyme called CYP3A4 which you are not able to stop taking
- Are still having side effects from earlier treatment
- Have a reduced immune system
- Have any condition that means you can’t absorb drugs from your stomach or bowel
- Have had another cancer that the doctors think may start to grow again
- Have any other serious medical condition
This is a phase 2 trial. It will recruit about 140 men with prostate cancer that has spread.
This is a randomised trial. The men taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.
- Group 1 have docetaxel and saracatinib
- Group 2 have docetaxel and a dummy tablet (placebo)
You have docetaxel through a drip into a vein once every 3 weeks. Each 3 weeks of treatment is called one cycle and you will have up to 10 cycles. Docetaxel is a standard treatment for this group of patients.
You will either take saracatinib or placebo tablets once every day, depending on which group you are in. You start taking the tablets 7 days before your first dose of docetaxel.
You will keep taking saracatinib or placebo tablets unless there are signs that your cancer has started to grow again, or you have serious side effects. If this happens you will stop and your doctor will discuss other treatment options with you.
If you agree to take part in this trial, the research team will ask you if they can take extra blood and urine samples to help them with their future research. If you don't want to give these samples, you don't have to. You can still take part in the trial.
You see the doctors and have some tests before you start treatment as part of this trial. The tests include
- Physical examination
- Heart rate, blood pressure and pulse
- Blood tests (including a PSA test)
- Urine test
Heart trace (ECG)
- CT scan or MRI scan
- Bone scan
- Chest X-ray
At the beginning of each 3 week cycle of treatment you fill out a questionnaire about any pain you are having.
You see the trial doctors once every 3 weeks while you are having treatment. You have a physical examination, blood tests (including a PSA test) and a urine test at each visit.
About a month after you finish treatment you have a CT or MRI scan, bone scan, chest X-ray, blood tests and urine test. You see the doctors and have a PSA test about every 6 weeks after that.
Saracatinib is a new drug so there may be side effects that the trial team don’t know about yet. Side effects we know about so far include
- A drop in red blood cells and white blood cells
- A temperature
- Feeling or being sick
- Liver problems
- A change in the level of ‘salts’ such as sodium, potassium and creatinine in your body
The most common side effects of docetaxel include
- A drop in blood cells
- A rash
- Discoloured fingernails
- Soreness on your hands and feet
- Hair loss
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.
Dr Rob J Jones
Beatson Oncology Centre
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NHS Greater Glasgow and Clyde
NIHR Clinical Research Network: Cancer
University of Glasgow
This is Cancer Research UK trial number CRUKE/10/043.