Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

This research is investigating a new treatment approach for men with prostate cancer that has spread to other parts of the body, even after they've already received some treatment. The study is testing two existing medicines, abemaciclib and darolutamide, used together. Abemaciclib is a type of drug that can stop cancer cells from growing and dividing, while darolutamide is a hormone therapy often used for prostate cancer. The researchers want to see if using these two drugs at the same time is safe and effective in slowing the progress of the cancer. This is an early-stage study, meaning it's primarily looking at how safe the combination is and what side effects it might have.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Eli Lilly & Co.

Enrolment target

Start

30 Nov 2023

Prostatic Neoplasms

What is this study about?

This study is about a new way to treat prostate cancer, specifically for men whose cancer has spread to other parts of their body, even after they've already had some treatment. Prostate cancer can sometimes become more aggressive and harder to treat, so doctors are always looking for new and better options.

The main idea behind this study is to combine two medicines that are already known, but usually used separately. One medicine is called abemaciclib. It works by blocking certain signals within cancer cells that tell them to grow and multiply. The other medicine is darolutamide, which is a type of hormone treatment commonly used for prostate cancer. Hormone treatments aim to reduce the amount of male hormones that prostate cancer cells need to grow.

By putting these two medicines together, researchers hope to find a more powerful way to fight the cancer. This is one of the first studies looking at this specific combination, so it's an important step in understanding if it could be a helpful treatment for men with this type of advanced prostate cancer in the future. The trial aims to find out if this combination is safe and what effects it has on the cancer.

Key takeaways

New combination treatment for advanced prostate cancer.
Investigates two existing drugs: abemaciclib and darolutamide.
Aims to check safety and effectiveness in slowing cancer growth.
For men whose cancer has spread after initial treatments.
Early-stage study, looking for new treatment options.

Who may be eligible?

This study is looking for men who have prostate cancer that has spread to other parts of their body, and who have already tried some other treatments for their cancer. You need to be at least 18 years old to take part.

Because this is a specific type of study, there will be other rules about who can join. For example, doctors will need to check your general health, how well your kidneys and liver are working, and what other medical conditions you might have. These checks are to make sure the treatment is as safe as possible for you and that you meet the study's requirements.

It's important to remember that even if you meet the main age and cancer type criteria, the study doctors will go through a full list of things to decide if this particular treatment and study are suitable for you. They want to make sure it's safe 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 a man?
Are you 18 years old or older?
Do you have prostate cancer that has spread?
Have you already had some treatment for your prostate cancer?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely have regular visits to the hospital or clinic. These visits would involve check-ups with the study doctor, blood tests, and scans to see how the cancer is responding and to monitor your general health. You would also be taking two study medicines, abemaciclib and darolutamide, usually in pill form. The full duration of your participation would depend on how your cancer responds to the treatment and what side effects you might experience, but these types of studies often involve several months or even longer of active treatment and follow-up. There will be planned follow-up appointments even after you stop taking the study medicines to monitor your health in the longer term.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of this study is that the new combination of medicines might help to control your prostate cancer better than existing treatments, or it might offer a new treatment option if other therapies haven't worked. However, there's no guarantee the treatment will work for you. Potential risks include experiencing side effects from the medicines, as all medications can have these. The study team will explain all known and possible side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Spain
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Unverified
Germany

Common questions

What type of prostate cancer is this study for?

This study is for men with prostate cancer that has spread to other parts of their body, even after receiving previous treatments.

What medicines are being tested?

The study is testing a combination of two medicines called abemaciclib and darolutamide.

Is this a new medicine?

No, both abemaciclib and darolutamide are existing medicines, but this study is looking at using them together for the first time in this specific situation.

What is the main goal of this study?

The main goal is to find out if this combination of medicines is safe and helps to control the spread of prostate cancer.

How long would I need to be in the study if I join?

The length of your participation would depend on how your cancer responds and your health, but it often involves several months of treatment and follow-up.