AuthorisedTherapeutic confirmatory (Phase III)Interventional

CYPENZA - A prospective cohort trial on antiandrogens influences on the pharmacokinetics of corticosteroids.

This study, called CYPENZA, is for men with prostate cancer. We are looking at how certain prostate cancer medications, specifically enzalutamide (Xtandi) or apalutamide (Erleada), might affect a steroid medication called dexamethasone (Dexacur). Dexamethasone might be used for various reasons, including to manage side effects of cancer treatments. We want to understand if these antiandrogen drugs change how much dexamethasone stays in your body and for how long. We will compare dexamethasone levels before and after you've been taking the antiandrogen. We will also check if giving a higher dose of dexamethasone can make up for any changes caused by the antiandrogen medicines. The aim is to ensure patients get the right amount of medication for their health needs.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Region Vaesterbotten

Enrolment target

Start

05 Feb 2026

Prostate cancer

What is this study about?

This study, called CYPENZA, is about understanding how two common prostate cancer medicines, enzalutamide (also known as Xtandi) and apalutamide (also known as Erleada), might affect how another medicine called dexamethasone works in your body. Dexamethasone is a type of steroid medication that can be used for a number of reasons, including to help manage side effects from cancer treatments or other health issues.

We know that some medicines can change how quickly your body uses up or gets rid of other medicines. In this study, we're particularly interested in whether enzalutamide or apalutamide speed up or slow down how your body handles dexamethasone. By measuring the amount of dexamethasone in your blood before and after you've been taking one of these antiandrogen drugs, we can see if there's a difference.

This kind of research is important because it helps doctors make sure that patients are getting the correct doses of all their medications. If one medicine changes how another one works, doctors might need to adjust the dose to make sure it's still effective and safe. We will also explore whether giving a slightly higher dose of dexamethasone can help if the prostate cancer drugs do reduce its levels in the body.

Key takeaways

Understanding how prostate cancer drugs (enzalutamide or apalutamide) affect other medicines (dexamethasone).
Measuring the levels of dexamethasone in your blood.
The study involves several clinic visits and blood tests.
Aims to improve how doctors manage medication for prostate cancer patients.
Open to men with prostate cancer, aged 18 and over.

Who may be eligible?

This study is looking for volunteers who are adult men, 18 years old or older. There is no upper age limit, meaning older adults are also welcome to participate.

To join, you would need to have been diagnosed with prostate cancer and be taking one of the specific medications we are studying: enzalutamide (Xtandi) or apalutamide (Erleada).

Other health conditions or medications you might be taking will be carefully reviewed by the study team to make sure it's safe and appropriate for you to take part.

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.

Are you an adult man?
Are you 18 years old or older?
Do you have prostate cancer?
Are you currently taking enzalutamide (Xtandi) or apalutamide (Erleada), or are you about to start taking one of them?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will have several visits to the study clinic. During these visits, the medical team will give you a single dose of dexamethasone, and then they will take several blood samples over a set period. This helps them measure how much dexamethasone is in your blood and for how long it stays there. This process will happen at three separate occasions: once before you start treatment with enzalutamide or apalutamide, and then again after you've been taking one of these antiandrogen medicines for a while. At one of these later visits, you might receive a slightly higher dose of dexamethasone to see how your body handles it. The total time you'd be involved in the study would depend on your treatment schedule, but it would involve a series of clinic visits over several weeks or months to collect the necessary blood samples.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is helping doctors understand how different medicines interact, which can lead to better treatment plans for prostate cancer patients in the future. You might also receive careful medical monitoring. Potential risks include discomfort or bruising from blood draws, and possible side effects from dexamethasone, which the study team will monitor closely. You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Sweden

Common questions

What is dexamethasone?

Dexamethasone is a steroid medicine that can reduce inflammation and is used for many conditions, including sometimes alongside cancer treatments.

What are enzalutamide and apalutamide?

These are medicines used to treat prostate cancer, known as antiandrogens, which work by blocking hormones that can fuel cancer growth.

Will my prostate cancer treatment change if I join?

The study aims to understand interactions; your main prostate cancer treatment schedule with enzalutamide or apalutamide will continue as prescribed.

How many times will I need to give blood?

You will have several blood samples taken during each of your three study visits to track medicine levels.

Why is this study important?

It helps doctors understand how prostate cancer drugs affect other medicines, ensuring future patients get the right doses for effective and safe treatment.