Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to assess how radium-223 moves through the patients with prostate cancer receiving radium-223 dichloride treatment.

This research is focused on understanding how a specific medicine, radium-223 dichloride, behaves inside the bodies of men who have prostate cancer and are being treated with this drug. Doctors want to see how it's absorbed, where it goes, and how it leaves the body. This type of study, often called a Phase I study, is a very early stage of research. It helps scientists learn important details about new treatments, such as how they move through the body. This information is crucial for ensuring the medicine is used as safely and effectively as possible for future patients with prostate cancer. The study is for adult men aged 18 and older.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Bayer Consumer Care AG, Bayer AG

Enrolment target

Start

21 Feb 2024

Prostate cancer

What is this study about?

This study is a step forward in understanding a treatment for prostate cancer called radium-223 dichloride. Imagine taking a medicine – doctors want to know what happens to that medicine once it's in your body. How quickly does it get into your system? Where does it go? How long does it stay there? And how does your body get rid of it? This study aims to answer these kinds of questions specifically for radium-223 in men with prostate cancer.

By carefully tracking how radium-223 moves through your body, researchers can learn a lot. This information helps them understand if the drug is reaching the right places and if it's being processed as expected. This knowledge is really important for a few reasons. Firstly, it helps ensure that the medicine is given in the safest and most effective way. Secondly, it contributes to a wider understanding of how this treatment works against prostate cancer, which can benefit many future patients.

This is a "Human Pharmacology (Phase I)" study. This means it's one of the first studies involving humans, designed to learn fundamental things about a drug's behaviour in the body, rather than testing its full effectiveness yet. It's a foundational step in bringing new and better treatments to patients.

Key takeaways

Study examines how radium-223 medicine moves through the body.
For men with prostate cancer receiving radium-223 treatment.
Helps doctors understand drug processing for safer, better use.
Involves extra blood/urine tests during treatment visits.
You can stop participating at any time.
Your participation helps future patients.

Who may be eligible?

This study is looking for men who have prostate cancer. To take part, you need to be an adult, specifically aged 18 years or older. There is no upper age limit, meaning older men are also able to join if they meet other health criteria.

Generally, participants would be those already receiving or about to receive treatment with radium-223 dichloride for their prostate cancer. The study will likely have other health requirements that your doctor would need to check, such as your overall health, liver and kidney function, and other medications you might be taking.

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?
Are you 18 years old or older?
Do you have prostate cancer?
Are you receiving or about to receive radium-223 treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve a series of visits to the clinic. During these visits, doctors and nurses would take blood and urine samples at specific times to measure how the radium-223 drug is moving through your body. You would continue to receive your radium-223 dichloride treatment as prescribed by your doctor. There might also be other health checks, like physical exams or questionnaires, to monitor your well-being. The total length of your involvement in the study would depend on your treatment schedule and the specific measurements needed, but typically these kinds of studies involve a number of assessments over several weeks or months, aligning with your treatment.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you would be closely monitored, and your participation helps doctors learn more about the radium-223 treatment, which can help others in the future. However, there may be some risks, such as discomfort from blood draws or unexpected side effects from the medication, although radium-223 is an approved treatment. You will be given full details of any known risks. Importantly, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Austria
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Unverified
Italy
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Unverified
Lithuania
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Unverified
France

Common questions

What is radium-223 dichloride?

Radium-223 dichloride is a medicine used to treat some types of prostate cancer that have spread to the bones.

Why is this study being done?

This study aims to understand how radium-223 moves through and is processed by the body in men with prostate cancer, to help ensure it's used as effectively and safely as possible.

Will I get special treatment in this study?

You will receive radium-223 treatment as prescribed by your doctor. The study adds extra monitoring and tests to understand the drug's behaviour, but it's not designed to test if the treatment works better.

Is this a new medicine?

No, radium-223 is an approved medicine. This study is about understanding how it works in the body more deeply.

What happens after the study finishes?

Once your participation in the study measurements is complete, you will continue to receive your standard medical care from your doctor.