Saracatinib (AZD0530) and docetaxel in metastatic castrate-refactory prostate cancer
Prostate cancer often responds well to hormone therapy at first, but the cancer can eventually stop responding and continue to spread. When this happens, chemotherapy is commonly used. This trial investigates whether adding a new targeted medicine called saracatinib to standard chemotherapy (docetaxel) works better than chemotherapy alone. Docetaxel is a standard chemotherapy medicine given through a drip, usually combined with a steroid tablet called prednisolone. Saracatinib is an experimental tablet designed to block key signals that cancer cells need to grow and spread to bones. Researchers are running this study in two stages. First, they want to establish the safest dose of saracatinib to give alongside docetaxel. Second, they aim to see if combining these treatments slows cancer growth and helps patients live longer compared to standard treatment.
At a glance
What is this study about?
Prostate cancer is one of the most common cancers in men. In its early stages, it usually relies on male hormones like testosterone to grow. Lowering hormone levels can keep the cancer under control for a long time. However, in some men, the cancer eventually adapts and begins to grow and spread again, even when hormone levels are very low. This is known as advanced or hormone-resistant prostate cancer.
When hormone therapy stops working, doctors often recommend chemotherapy using a drug called docetaxel. Docetaxel works by attacking rapidly dividing cancer cells. While docetaxel can shrink tumours and relieve symptoms, researchers are constantly searching for ways to make it more effective. In this study, scientists are testing whether adding an experimental drug called saracatinib improves outcomes.
Saracatinib works differently from chemotherapy. It blocks a specific protein inside cells called Src, which cancer cells use to survive, invade surrounding tissues, and spread to bones. By pairing saracatinib with docetaxel and a standard steroid called prednisolone, doctors hope to deliver a stronger dual attack against the cancer.
This trial is divided into two parts. The first part checks the safety of the drug combination and finds the best dose. The second part compares how well the combination works compared to standard chemotherapy alone. The ultimate goal is to provide men with advanced prostate cancer a better, more effective treatment option.
Key takeaways
- Tests a new targeted tablet, saracatinib, combined with docetaxel chemotherapy.
- Aimed at men with prostate cancer that has spread and stopped responding to hormone therapy alone.
- Designed to check drug safety and see if cancer growth can be slowed down.
- Requires regular hospital visits for drip infusions, blood tests, and scans.
- Participation is entirely voluntary and does not affect your right to standard NHS care.
Who may be eligible?
This trial is open to men aged 18 and over who have been diagnosed with advanced prostate cancer that has spread to other parts of the body, such as the bones or lymph nodes. To be eligible, your cancer must show signs of progressing—either through rising PSA blood test levels or new spots appearing on scans—even though your testosterone levels are kept very low by hormone treatments.
You will need to be reasonably active and able to look after yourself in daily life, with satisfactory blood test results showing that your liver, kidneys, and bone marrow are working well enough to safely handle chemotherapy. You must also be able to swallow tablets.
You cannot take part if you have already received chemotherapy for your prostate cancer in the past. You may also be unable to join if the cancer has spread to your brain or spinal cord without being successfully treated, if you have had other severe cancers recently, or if you have had bad allergic reactions to chemotherapy ingredients before.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am a man aged 18 or older.
- I have prostate cancer that has spread to other areas (such as bones).
- My cancer is growing or my PSA is rising despite hormone treatment.
- I have not previously had chemotherapy for my prostate cancer.
- I am able to look after myself and swallow daily tablets.
What does participation involve?
If you take part, you will receive treatment in cycles, usually lasting three weeks each. Docetaxel chemotherapy is given as an infusion through a small tube into your vein at the hospital on the first day of each cycle. You will also take prednisolone steroid tablets and saracatinib tablets daily by mouth at home.
Throughout the study, you will have regular hospital visits for safety checks. These will include blood tests to check your blood cells, kidney and liver function, and PSA levels. You will also have periodic imaging scans, such as bone scans or CT scans, to see how your tumours are responding.
Your medical team will closely monitor any side effects you might experience. Treatment usually continues for several months as long as the cancer does not worsen and the side effects remain manageable. After finishing treatment, the team will continue to check on your health and well-being during regular follow-up appointments.
Potential risks and benefits
Locations (1)
- Cancer Research UK Clinical Trials UnitUnverifiedGlagow, Scotland
Common questions
What is the main purpose of this trial?
The study aims to find out if adding an experimental drug, saracatinib, to standard docetaxel chemotherapy is safe and helps treat advanced prostate cancer more effectively.
Do I have to stop my current hormone therapy to take part?
No, you must continue treatments that keep your testosterone levels low, as keeping testosterone suppressed remains an essential part of your cancer care.
How is the study medication taken?
Docetaxel is given through a drip in your vein at the hospital, while saracatinib and prednisolone are tablets you swallow at home.
Can I leave the study if I feel it is not right for me?
Yes, you are free to withdraw from the trial at any stage without giving a reason, and your medical team will move you to the next best standard treatment option.
Will taking part cost me anything?
No, the trial drugs and any extra tests are provided free of charge, and some hospital travel expenses may be reimbursed depending on local trial arrangements.
How to find out more
Rob Jones
Always speak to your GP or specialist before deciding to take part in a study.
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