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In 2012, the drug abiraterone (Zytiga) was first made available on the NHS to treat men with advanced prostate cancer that has stopped responding to standard hormone treatment.

Now, a strong case is being made for the drug to be made available to even more men with prostate cancer.

According to results from the Cancer Research UK-funded STAMPEDE clinical trial, offering abiraterone plus prednisolone in combination with standard therapy to men with prostate cancer earlier, before the disease becomes resistant to standard hormone therapy, can help boost survival.

That’s the take home message from new findings presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in the US.

The results of the trial, also published recently in the New England Journal of Medicine, show that giving this combination to men whose prostate cancer has spread, or has a high risk of doing so, extends their lives.

Experts have said the results could be practice-changing. So what would this mean for men with prostate cancer?

What did the trial look at?

The STAMPEDE trial is many different trials in one. It’s looking at new combinations of treatments for prostate cancer patients to see which, if any, can improve survival.

Results from some parts of the trial have already been reported. And other parts are still open and available for patients to join.

The part of the trial presented today focused on abiraterone, a drug our research played a leading role in discovering and developing. It works by blocking a molecule inside cells, which stops the body from producing the hormone testosterone. This is important for prostate cancer as testosterone can fuel the growth of tumour cells.

The STAMPEDE team wanted to see if combining abiraterone plus the steroid prednisolone with standard hormone therapy – which blocks or lowers the amount of testosterone in the body – reduced the chances of the disease coming back, or improved survival.

Combining the two could therefore be a double whammy – it would stop cancer cells using testosterone as a fuel to grow, and prevent the production of more testosterone.

It’s one of the biggest improvements in overall survival I’ve seen

– Professor Nick James 

Approximately 1,900 men with prostate cancer who were at a high risk of their disease spreading, or who have prostate cancer that has already spread, took part in the trial and were followed for just over 3 years.

Just under half were treated with standard hormone therapy. The others were treated with standard hormone therapy plus abiraterone and prednisolone.

“We know androgen deprivation therapy works well for a lot of men with prostate cancer. But we wanted to see if we could improve things further,” says Professor Nick James, chief investigator of the STAMPEDE trial based at the University of Birmingham.

“That’s why we looked at combining abiraterone with hormone therapy – to see if this drug could give even more men with prostate cancer even more time with their family.”

The results

When comparing the 2 groups, the researchers looked for 2 key results:

  • Was there any difference between the groups in terms their disease coming back after treatment?
  • Was there a difference between the 2 groups in terms of how many men survived after treatment?

What they found was something James describes as ‘the most powerful results’ he’s seen from a prostate cancer clinical trial.

Men who received the combination of abiraterone plus prednisolone and hormone therapy were far less likely to see their disease spread or get worse compared to those who received only hormone therapy.

But that doesn’t necessarily mean that these men were likely to live longer.

That’s why James and his team also looked at whether the combination improved survival. And it did.

They found that there were fewer deaths in the group who received the combined treatment (184 vs 262). And those men who received the combination were far more likely to be alive 3 years after treatment than those receiving hormone therapy only.

“It’s one of the biggest improvements in overall survival I’ve seen in any clinical trial for adult cancers,” says James. “To be part of something like this is a once in a career feeling.”

He’s also keen to point out that not only does this new combination improve survival and reduce the chances of a man’s cancer coming back, it also does so with fewer side effects.

I really hope these results can change clinical practice

– Professor Nick James 

“As well as improving survival this drug combination also reduced severe bone complications, a major problem for prostate cancer patients, by more than 50%,” he says.

Results from another prostate cancer clinical trial, called LATITUDE, also presented at the conference and published in the New England Journal of Medicine alongside the STAMPEDE trial results.

Excitingly, this trial shows that combining abiraterone and standard hormone therapy lowers the risk of death in men whose prostate cancer has already spread at the time of diagnosis.

The combined treatment also more than doubled the time before patients’ disease worsened, again signalling promise for offering abiraterone earlier in these men.

The potential impact

The purpose of clinical trials is to test new drugs and combinations of drugs to see if they’re better than existing treatments.

In the case of this part of the STAMPEDE trial, it’s certainly done the latter.

And for James, it’s something he hopes will change how men with prostate cancer are treated.

“For me, these results mean abiraterone combined with androgen deprivation therapy should be the new standard of care for men with early stage prostate cancer,” he says.

“I really hope these results can change clinical practice and that this drug can now be used to treat more men with prostate cancer, not just those with advanced disease.”

Áine

References

Fizazi, K. et al. (2017) Abiraterone plus Prednisone in Metastatic Castration-Sensitive Prostate Cancer. The New England Journal of Medicine. DOI: 10.1056/NEJMoa1704174

James, N.D. et al. (2017) Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. The New England Journal of Medicine. DOI: 10.1056/NEJMoa1702900

Comments

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Marshall Kinnear August 17, 2017

Are the drugs mentioned in tour report available to NHS doctors in Scotland?

Aine McCarthy August 14, 2017

Hi Ian,

Recruitment for this part of the STAMPEDE clinical trial is now closed, but there are other parts of the trial looking at different treatments that are still open. If you or someone you know would like to join STAMPEDE, or any other clinical trial, the best thing to do is speak to your doctor. They will be able to help you find out if there are any suitable trials available to you.

Best wishes,

Cancer Research UK

Ian August 13, 2017

A fascinating report, thank you. Is there any way one can participate in a trial with this treatment?

Elise Tshikaji August 10, 2017

Hi,i would like to have the informations on research in some fields in nursing,starting date:available now.Elise

Gerry Leach August 4, 2017

This news is groundbreaking for all whom suffer from this disease and pressure has to be brought to bear on N.I.C.E To make these drugs available to ALL and NOT a Post code lottery excercise.

Aine McCarthy August 4, 2017

Hi all,

Thanks for your comments. Based on these new results from the STAMPEDE trial, we hope NICE will recommend abiraterone plus the steroid prednisolone combined with standard hormone therapy as a first treatment for men whose prostate cancer has spread or has a high risk of doing so soon.

NICE (in England, Wales and Northern Ireland) and the SMC (in Scotland) set guidelines about what treatments should be available on the NHS. These organisations take into account a range of evidence including clinical trial results, and balance many different factors to make decisions about what treatments will have the best outcomes for patients.

We’re still waiting to hear when they will review their guidelines in light of these new results from the STAMPEDE trial. We continue to engage with NICE and SMC on improving patient access to new evidence-based cancer medicines.

Abiraterone is available now on the NHS as a treatment for men with advanced prostate cancer that has stopped responding to standard hormone treatment (http://scienceblog.cancerresearchuk.org/2012/05/16/abiraterone-now-available-on-the-nhs-except-in-scotland/). Speak to your doctor about whether or not abiraterone could be suitable for you or someone you know with prostate cancer.

Best wishes,
Áine, Cancer Research UK

John Staniforth August 3, 2017

I have read about some of this before from Stampede Trial ( which I am participating in).

So why aren’t we being given these additiional drug combinations yet?

I do hope that the bodies involved in hopefully fast-tracking the use of such combinations of drugs do not drag their feet – as I am not getting any younger and my PSA keeps inexorably rising.

John Renshaw August 3, 2017

Sounds very interesting and promising progress on the project and I am bearing this in mind

Cathy August 3, 2017

My husband was put onto this trial when diagnosed with advanced metastatic prostate cancer in Feb 2013. His PSA dropped and remains under 0.03% since. We are now in August 2017 so for him this treatment has definitely proved a huge success. The research into cancer is producing some excellent results thank God.

A Penny August 3, 2017

This is fantastic news but will the government fund this on the NHS. If they allow it, will it be another postcode lottery of who gets the treatment. My uncle has been suffering from aggressive prostate cancer for over ten years, they said treatment similar to this could help. But then was put on a different treatment. No reason was given and now it’s basically a waiting game for the inevitable!

Colin Webb August 3, 2017

All very good, but how many years will it take before common use. I am speaking as someone who has had prostate cancer, had 2 months of radiotherapy and now find my PSA increasing again.

Robert Shovelton August 3, 2017

I think this is a very exciting discovery

Graham Bushnell-Wye August 3, 2017

How effective might this approach be for prostate cancer that has spread to lymph nodes but not yet to bones? I’ve had chemotherapy and ongoing hormone treatment but I’m concerned that the cancer will continue to spread despite a low PSA at the moment.

David Pinion August 3, 2017

Does this do anything to help prostrate cancer ,recently diagnosed and on last dose of chemo,that had spread to my pelvic bone. PSA running now at 0.3 for several months.

Aine McCarthy June 28, 2017

Hello,
Thanks for the question.

Both the STAMPEDE and the LATITUDE clinical trials looked at adding abiraterone (Zytiga) to standard hormone therapy and a steroid (prednisone or prednisolone). But, they differ in relation to the groups of men they included.

The STAMPEDE trial was looking at combining abiraterone, prednisolone and standard hormone therapy as a treatment for men with prostate cancer that had spread or who were at a high risk of their disease spreading. The results were published in the New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa1702900?query=featured_home).

The results of the LATITUDE trial were also published in the New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa1704174?query=featured_home) and looked at the same combination of drugs – abiraterone and standard hormone therapy – but this time with a different steroid prednisone. This study was also different because it looked at men whose prostate cancer had already spread at the time of diagnosis, and who had not yet been given hormone treatment.

It’s a subtle but important difference. You can read more about these trials on our website (http://www.cancerresearchuk.org/about-us/cancer-news/news-report/2017-06-03-giving-prostate-cancer-drug-earlier-extends-lives-of-men-whose-disease-has-spread?_ga=2.41327073.217671705.1498469716-1079042811.1485172819).

Áine

matua (@chaichairobot) June 22, 2017

i’m not sure if it’s just me, but the study that you said was published in New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa1704174?query=featured_home) is not the STAMPEDE trial but the LATITUDE trial. The STAMPEDE trial made use of ADT plus abiraterone. The LATITUDE trial is the one that used ADT plus abiraterone and prednisolone.

pallavi June 16, 2017

yes the results can change clinical practice scientists done a great job
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Pamela Hale June 8, 2017

Great news about prostate cancer, congratulations to research scientists.It makes all our groups Cruk funding raising worth worthwhile.