Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Determining the clinical relevance of the interaction between enzalutamide and the opioid morphine and the DOAC edoxaban to improve rational pharmacological care of patients with prostate cancer

This research is investigating how a common prostate cancer treatment called enzalutamide interacts with other important medicines. Specifically, it's looking at how enzalutamide might change the way your body handles morphine, which is used for pain relief, and edoxaban, a medication that thins the blood. Understanding these interactions is vital because many patients with prostate cancer need these different types of drugs. By seeing how they affect each other, doctors can provide safer and more effective treatment plans. The study will also check how well pain is controlled and look for any side effects when these medicines are used together.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Radboud universitair medisch centrum Stichting

Enrolment target

Start

15 Nov 2024

Prostate cancer

What is this study about?

This study is very important for men living with prostate cancer, especially those who also need other medications. We know that as prostate cancer progresses, patients might experience pain and could be at risk of blood clots. To manage these, doctors often prescribe pain relievers like morphine, and blood thinners such as edoxaban.

However, when you take several different medicines at the same time, they can sometimes affect how each other work. This study aims to understand exactly how the prostate cancer drug enzalutamide interacts with morphine and edoxaban. Researchers want to see if enzalutamide changes how much of morphine or edoxaban stays in your body, and for how long. This kind of information is crucial for doctors to prescribe the correct doses and ensure these medicines are both safe and effective when taken together.

Ultimately, the goal is to improve the care for men with prostate cancer by providing doctors with clear guidelines. If we know how these drugs interact, doctors can make better decisions about what medicines to prescribe and at what dose, ensuring that patients receive the best possible treatment with minimal side effects. This could lead to better pain control and safer blood thinning for patients also taking enzalutamide.

Key takeaways

This study investigates how prostate cancer drug enzalutamide interacts with morphine and edoxaban.
It aims to improve safe and effective use of multiple medicines for prostate cancer patients.
Participation involves blood tests to check drug levels and monitoring for side effects.
The findings will help doctors provide better care for men taking these combinations of drugs.
You can withdraw from the study at any time if you choose to.

Who may be eligible?

This study is open to men of any age who have prostate cancer and are taking or are expected to take enzalutamide.

Participants may also be taking morphine for pain relief or edoxaban as a blood thinner, or both. The study needs to include men taking these specific combinations of medicines to properly understand how they interact.

More specific details about your medical history and other medications you might be taking would be discussed with the study team to see if the study is a good fit for you.

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 a man?
Do you have prostate cancer?
Are you currently taking enzalutamide, or are you expected to take it?
Are you also taking morphine for pain relief?
Are you also taking edoxaban for blood thinning?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would continue to take your prescribed medicines (enzalutamide, and possibly morphine and/or edoxaban) as usual. The primary focus of the study involves measuring how much of these medications are in your bloodstream at different times. This will likely involve giving blood samples at specific intervals after taking your medication.

For those taking morphine, the study will also check your pain levels using a simple scale to see how well your pain is being managed. Throughout the study, the research team will also carefully monitor you for any side effects from the medications. The exact number of visits, tests, and the total duration in the study will be explained in detail by the study team, but it will involve careful and regular monitoring.

Potential risks and benefits

Taking part in this study may help us understand medicine interactions better, which could ultimately lead to safer and more effective treatments for other men with prostate cancer in the future. As with any study involving medicines, there might be some risks, such as discomfort from blood draws or potential side effects from the medications themselves, though these will be closely monitored. You will be told about all known risks before you decide to join. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time 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
Netherlands

Common questions

What is enzalutamide?

Enzalutamide is a medicine used to treat prostate cancer.

What are morphine and edoxaban used for?

Morphine is a strong pain reliever, and edoxaban is a blood thinner used to prevent blood clots.

Why is this study important for me?

This study aims to ensure that if you're taking enzalutamide along with morphine or edoxaban, these medicines work safely and effectively together.

Will I have to stop taking my current medicines?

No, you would continue to take your prescribed medicines as usual for the study.

What does 'monitoring for side effects' mean?

It means the study team will carefully check on you during the study for any unwanted effects or changes in your health caused by the medicines.