HCP FAQs: Abiraterone for High-Risk Non-Metastatic Prostate Cancer
Abiraterone for high-risk, or locally advanced, non-metastatic and relapsing localised prostate cancer has been approved in England.
What’s changed and why it matters?
What are the benefits of this medication?
- As shown by the STAMPEDE trial, addition of abiraterone to standard of care (SOC) treatments reduces disease progression and increases survival.
How will treatment differ for this group of men now that abiraterone is approved?
- Men who are eligible will now be offered 2 years of abiraterone (and prednisolone) on top of a combination of ADT and radiotherapy (RT).
Who is eligible (and when)?
Which men will be eligible and when will they get access?
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Eligible men are those who have been diagnosed with high-risk localised, or locally advanced, prostate cancer. Also, men who have relapsing prostate cancer with high-risk features.
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Eligibility criteria recommendations will be the same as the STAMPEDE protocol – the first dose of abiraterone must be given within a 12-week time period of starting on ADT. ADT must be started prior to starting abiraterone.
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It is likely that men who are currently self-funding their own abiraterone treatment in this indication, either through co-pay arrangements or by sourcing it independently, will need to be discussed at an MDT first before they can be switched onto free NHS treatment.
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Patients who have started taking abiraterone via an alternative funding route will be able to move to NHSE supply as long as when they started taking the treatment, it was within 3 months of starting ADT.
Availability
- We have been informed that abiraterone will be available immediately on the NHS. However, in practice, there may be a slight delay as trusts set up their allocations for appointments and prescriptions.
URGENT ACTION: audit requirement
What happens to suitable men who were diagnosed before 16th Jan 2026?
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The evidence from the STAMPEDE trial shows abiraterone should be given within 12 weeks of starting ADT. That means that patients who began ADT more than 12 weeks ago will not be eligible.
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We urge clinicians to carry out a rapid audit of diagnoses that have occurred within the last 12 weeks to identify who would benefit and ensure that they are rapidly started on abiraterone to ensure that suitable patients do not “time-out” of eligibility.
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If patients have been diagnosed with high-risk prostate cancer and started on ADT within the last 12 weeks and are concerned about whether or not they would benefit from adding abiraterone to their treatment, they should contact their clinical team as a matter of urgency.
How the treatment is given?
Is the medication taken alone?
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Abiraterone needs to be taken with a steroid (prednisolone) to help manage its side effects.
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For localised high-risk prostate cancer it is taken for two years in combination with ADT treatment, and usually after radical radiotherapy unless contraindicated. In comparison, men with metastatic prostate cancer take it indefinitely until it stops working.
How does abiraterone work?
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Abiraterone stops the body producing testosterone which the cancer cells need to grow.
Risks and side effects
Are there any risks associated with this medication?
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It can cause side effects. Our knowledge of its side effects comes largely from men taking it as a treatment for metastatic prostate cancer, so it’s not fully clear if there are differences in this setting.
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The most common side effects are: fluid retention; low potassium; liver problems; high blood pressure; urinary tract infection; diarrhoea.
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Experiencing side effects is slightly more likely for combination therapy than for SOC. Trial data has shown that 37% of men on combination therapy suffer from side effects that affect their ability to do basic daily tasks, compared to 29% for those on SOC. There is also an increased risk of less severe side effects, such as hypertension and anaemia.
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Abiraterone also needs to be taken with steroids, which have their own side effects, listed here.
Is quality of life different between this medication and SOC?
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Quality of life is comparable between those that use SOC and those that take combination therapy (abiraterone + SOC). For a number of adverse side effects, there was little difference between SOC and combination therapy.
Exclusions
What are the exclusion criteria?
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Patients with contraindications to abiraterone acetate.
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Patients with confirmed clinically significant cardiovascular disease, including severe angina, recent myocardial infarction or a history of cardiac failure.
Background (for reference)
What was the standard of care pre-January 2026?
- The standard of care in England for this indication was a combination of ADT and RT or ADT alone. Other options included brachytherapy or docetaxel chemotherapy.
What about Northern Ireland?
- At the moment we do not know whether Northern Ireland will be following suit. We are looking into this and will update in due course.