Docetaxel chemotherapy alongside hormone therapy
The story in a nutshell
In 2015 the STAMPEDE trial reported that men with metastatic prostate cancer (cancer that has spread to other parts of the body) who were taking docetaxel chemotherapy at the same time as hormone therapy lived for an average of 15 months longer than those taking hormone therapy alone. This is a real game changer in the battle against prostate cancer, and Prostate Cancer UK has been working to speed up the process of ensuring that men who need this treatment can get it.
Men need early access to this drug. Why the delay?
The patent for docetaxel has expired, which means that any pharmaceutical company is free to make and sell the drug. This means that, unlike when a new drug is licensed, there is no commercial incentive for any company to push for earlier docetaxel to be made available . It’s also worth pointing out that, even if this was possible, the timeline for appraisals is often very long. In the absence of a clear-cut pathway to access, we’ve been working closely with researchers, health professionals and commissioners to get things moving.
Tell us your story
If you have been diagnosed with metastatic prostate cancer, and are suitable for hormone therapy, but are struggling to access docetaxel please let us know. You can help us take action by telling us where problems exist.
What we’ve been doing
In addition to publicly highlighting the challenges of making this new treatment available to men throughout the UK, we also supported the Off-patent Drugs Bill, which was intended to overcome these challenges.
We then raised this issue directly with NHS England, who is responsible for funding specialist cancer drugs. As a result we worked with them to ensure that this drug is routinely available to all men who need it as soon as possible. We'll continue to keep our ear to the ground, to ensure that any man who is eligible for docetaxel alongside hormone therapy is able to access it.
Without the pressure we exerted on NHS England to prioritise the development of this policy statement, they would not have started this work until the results of the STAMPEDE trial were published in a peer reviewed journal. This would have caused further delay to men accessing the drug.
In Scotland we wrote to the First Minister welcoming news that the treatment was available to patients in the west of Scotland and urged her to take action to ensure it was available throughout the country. Further to follow up discussions with Scottish Government officials, we understand the treatment is now available throughout Scotland.
We are also working in Wales and Northern Ireland, and we will work with key decision makers to ensure that the drug is available as soon as possible. We will update this page with news of progress.
Our work will continue until every patient who can benefit from having docetaxel alongside hormone therapy it is able to receive it, regardless of where they live in the UK.
Nigel's story
While many hospitals delay putting into action the staggering results of the STAMPEDE trials, more than 500 men with advanced prostate cancer a month are missing the chance to extend their lives by up to two years. We talked to one of them, Nigel, about the terrible toll the delays are taking on him and his family, and call on hospitals to end this cruel treatment lottery.
Your questions about STAMPEDE
We've told you about some exciting results from the STAMPEDE trial. These showed that giving chemotherapy earlier, at the same time as hormone therapy, to men whose prostate cancer has spread beyond the prostate and the surrounding area, can help keep them alive for longer.
This is good news, but we know it has raised lots of questions for men with advanced prostate cancer. We don’t know all the answers yet, but we’ve tried to address some of your questions below, and will keep you updated as we learn more.
The STAMPEDE trial is very big, and includes lots of different ‘arms’. Each ‘arm’ of the trial is testing something different. The investigators are reporting results from three arms of the trial at a big American cancer conference later this month. The arms being reported are:
• hormone therapy plus docetaxel chemotherapy
• hormone therapy plus zoledronic acid
• hormone therapy plus docetaxel chemotherapy and zoledronic acid
These results have already hit the headlines, and these trial arms are now closed to new patients (they are still continuing to follow-up the men who took part so they can find out the long-term effects of these drugs). However, other arms of the trial are still recruiting patients.
You can find out more on the STAMPEDE trial website. You can also speak to our Specialist Nurses.
Not necessarily. The results of this trial are really positive, but at the moment ‘standard treatment’ is still hormone therapy, not chemotherapy. We’re working hard to find out exactly what needs to happen to change standard practice across the UK so that it includes offering chemotherapy alongside hormone therapy as soon as a man is diagnosed with advanced prostate cancer.
Men in Scotland should be able to access this already. Work is currently underway to make this available to men in England, Wales and Northern Ireland as soon as possible, as detailed above. We’ll do everything we can to make that happen as soon as possible and we’ll keep you up to date with any developments.
Yes, you can ask about chemotherapy alongside hormone therapy outside of the STAMPEDE trial. If this is a treatment option you’d like to consider, we would recommend that you do speak to your oncologist about it. But we can’t guarantee that the answer will be yes.
Docetaxel chemotherapy is already available on healthcare systems across the UK for men whose prostate cancer no longer responds to hormone therapy. But the licence that allows docetaxel to be used in the EU (and the use that NICE [National Institute for Health and Care Excellence] have agreed to) doesn’t include its use before the cancer has become resistant to hormone therapy.
Having said that, doctors do have the freedom to prescribe drugs ‘off-licence’, if they think it will be in the patients’ best interest, and if the NHS Trust/Board that employs them will allow it. So if this is a treatment option you’re considering, asking your oncologist is your best bet.
If your prostate cancer hasn’t yet spread to other parts of the body, but has spread to the area just outside the prostate, you can still ask, but the STAMPEDE trial results we’ve seen so far don’t show a clear survival benefit from taking docetaxel alongside hormone therapy in this situation.
The researchers found that, on average, men with advanced prostate cancer (prostate cancer that has spread to other sites in the body) survived an extra 15 months. And the researchers said that they hope doctors will offer chemotherapy to all men newly diagnosed with advanced prostate cancer.
They also think that men with locally advanced prostate cancer (prostate cancer that has just started to spread out of the prostate) might want to consider having chemotherapy earlier on alongside hormone therapy, because it can give them longer before their cancer starts to grow again.
But the evidence doesn’t show a clear survival benefit from giving docetaxel chemotherapy at this stage, so your oncologist may not agree to prescribe you docetaxel alongside hormone therapy if your prostate cancer hasn’t yet spread.
We don’t know yet whether there’s benefit in giving docetaxel chemotherapy to men with advanced prostate cancer who have already been on hormone therapy for a while.
This trial only recruited men with locally advanced, or advanced disease, who needed to take hormone therapy for the first time. Men on the trial started hormone therapy a few weeks before starting chemotherapy. There may well be some benefit in having docetaxel chemotherapy even after a longer period on hormone therapy alone, but this wasn't specifically tested for.
But if this is a treatment you're interested in, it's worth having a chat to your oncologist about it.
No, we’re not. We think that when a man is diagnosed with advanced prostate cancer, he should have access to as many effective treatment options as possible. Some men will choose not to have chemotherapy, or won’t be strong enough to have chemotherapy, in which case, we’d like them to have the option of taking abiraterone when their hormone therapy stops working.
On the other hand, we’d like men to have the option of having chemotherapy earlier on in their treatment pathway, when they are newly diagnosed with advanced prostate cancer. The STAMPEDE trial, and previous data from another clinical trial called CHAARTED, has shown that this can help these men survive longer. It’s also worth considering that more men might choose to have chemotherapy earlier on, when they’re feeling stronger and better able to cope with the side effects.
