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AuthorisedTherapeutic use (Phase IV)Interventional

Standard dosed abiraterone versus Therapeutic Drug Monitoring guided abiraterone dosing – The Adapt Abi trial

This study, called 'Adapt Abi', is for men with advanced prostate cancer that has spread to other parts of the body and hasn't responded to initial hormone treatments (metastatic castration-resistant prostate cancer). It's looking at a common drug called abiraterone. Currently, everyone gets the same dose. This study wants to see if checking a patient's blood levels of the drug and then adjusting their dose could be more effective. The main thing they want to find out is if this personalised dosing can keep cancer from progressing (getting worse on scans) for a longer time. They will also look at how safe it is, how patients feel, and how long they live.

At a glance

Status
Authorised
Phase
Therapeutic use (Phase IV)
Sponsor
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Enrolment target
230
Start
07 Apr 2026

What is this study about?

Imagine you have prostate cancer that has spread, and your doctor has prescribed a medication called abiraterone. This drug is commonly used to help slow down the cancer's growth. Currently, most people get a standard dose of abiraterone, which is the same for everyone.

This study, called 'Adapt Abi', is looking into whether we can make this treatment even better. Instead of a one-size-fits-all approach, researchers want to see if regularly checking the amount of abiraterone in a person's blood and then adjusting their dose accordingly could lead to better results. This is a bit like how some other medications are managed, where doctors fine-tune the amount you take based on how your body is using it. The main aim is to see if this personalised dosing approach can keep the cancer from progressing (getting worse on scans) for a longer period.

They will also be carefully checking other important things. This includes understanding how practical and safe this new dosing method is, whether doctors follow the advice from the blood tests, if it improves a patient's quality of life (how they feel day-to-day), and ultimately, if it helps people live longer. This research is important because it could lead to more effective and personalised treatment options for men with advanced prostate cancer in the future.

Key takeaways

  • This study explores a personalised dosing approach for abiraterone.
  • It targets men with advanced prostate cancer that has spread.
  • The main goal is to see if adjusting doses based on blood tests can better control cancer growth.
  • The study will also assess safety, quality of life, and overall survival.
  • Taking part means regular blood tests and doctor visits.

Who may be eligible?

To be considered for this study, you would need to be an adult male, meaning aged 18 years or older, with prostate cancer.

Specifically, your prostate cancer must have spread to other parts of your body (known as metastatic) and no longer be responding to standard hormone treatments. This type of cancer is sometimes called 'castration-resistant' prostate cancer, meaning it's still growing despite treatments that lower male hormones.

The study team will review your medical history and test results to confirm if you meet all the necessary requirements to take part safely.

Quick self-check
  • Are you an adult male (18 years or older)?
  • Have you been diagnosed with prostate cancer that has spread to other parts of your body?
  • Is your prostate cancer still growing even after receiving hormone-lowering treatments?
  • Are you able to attend regular clinic appointments for blood tests and check-ups?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be taking the medication abiraterone, just like many people currently do for this type of cancer. The key difference is that your treatment plan might involve some extra blood tests to measure the level of abiraterone in your system. Based on these blood test results, your doctor might adjust the dose of your medication.

The study will involve regular visits to the clinic for these blood tests, check-ups, and to see how you are responding to the treatment and how you are feeling generally. You would continue with the medication and assessments for as long as it is helping you. The total duration of your participation would depend on how your cancer responds to the treatment and the study's follow-up schedule.

Potential risks and benefits

Taking part in this study may offer potential benefits in that adjusting your abiraterone dose based on your blood levels could potentially lead to a more effective treatment tailored to you, possibly keeping your cancer from progressing for longer. However, there is no guarantee that you will personally benefit. As with any medication, there are potential risks and side effects associated with abiraterone, and the blood tests might cause some minor discomfort. These risks will be fully explained by the study team. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

  • Netherlands

Common questions

What is 'metastatic castration-resistant prostate cancer'?

This is prostate cancer that has spread to other parts of the body and is still growing, even after treatments that lower male hormones.

What is abiraterone?

Abiraterone is a medicine used to treat advanced prostate cancer. It works by reducing the body's production of male hormones that can fuel cancer growth.

What does 'adjusting the dose based on blood tests' mean?

It means the amount of abiraterone you take might be changed by your doctor based on how much of the drug is found in your blood, aiming for the most effective level for you.

Will this study cure my cancer?

This study is not designed to cure cancer but to see if a different way of giving abiraterone can better control its growth and potentially improve how long patients live and feel well.

What is 'radiographic progression-free survival'?

This is a way to measure how long a patient lives without their cancer getting worse, based on what doctors see on scans like X-rays or CT scans.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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