A trial looking at docetaxel and saracatinib for prostate cancer that has spread (SAPROCAN)

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 testosterone level 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 anti cancer 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 1 trial. It will recruit up to 18 men with prostate cancer that has spread. Everyone taking part will have docetaxel and saracatinib.

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 standard treatment for this group of patients.

You will also take saracatinib tablets once every day, starting 11 days after your first dose of docetaxel. The first few people taking part will have a lower dose of saracatinib. If they don’t have any serious side effects, the next few people will have a higher dose. And so on, until the research team find the best dose to give. This is called a dose escalation trial.

You will keep taking saracatinib 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.

The research team would like to take extra blood and urine samples to help them with their research. They will use the samples to look for markers that they hope will help predict which patients will benefit from this treatment in the future.

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

When you have the first 2 doses of docetaxel you stay in hospital for about 8 hours each time, and go back to hospital the following morning. This is so the research team can take some blood samples to find out more about what happens to the drugs in the body. After that, each dose of docetaxel should only take an hour or so.

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, 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
• Diarrhoea
• Tiredness
• 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
• Tiredness
• A rash
• Discoloured fingernails
• Soreness on your hands and feet
• Hair loss

We have more information about the side effects of docetaxel in our Cancer drugs section.