Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

SAFETY AND PHARMACOKINETICS OF ODM-208 IN PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

This research study, called a clinical trial, is testing a new medication called ODM-208. It's for men who have prostate cancer that has spread to other parts of their body (metastatic) and is no longer responding to standard hormone treatments (castration-resistant). The main goals are to find out if ODM-208 is safe and to determine the best dose to use. Researchers will also be looking at how the drug works in the body and if it helps to shrink tumours or slow down the cancer. This is an early-stage study, meaning it's one of the first times this drug is being given to people.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Orion Corporation

Enrolment target

129

Start

29 Oct 2024

Metastatic castration-resistant prostate cancer.

What is this study about?

This study is an early-stage clinical trial investigating a new drug called ODM-208 for men with advanced prostate cancer. This type of prostate cancer is known as 'metastatic castration-resistant prostate cancer'. 'Metastatic' means the cancer has spread from the prostate to other parts of the body. 'Castration-resistant' means the cancer is still growing even after treatments that lower male hormones, like testosterone.

The main purpose of this study is to check if ODM-208 is safe for people to take and to figure out the best dose. When a new drug is first given to people (often called 'first-in-human' studies), doctors need to carefully monitor for any side effects. They also want to understand how the drug behaves in the body, for example, how it's absorbed, distributed, broken down, and removed. This helps them work out the most effective and tolerable amount of the drug to give.

Researchers will also be looking for early signs of how well ODM-208 works. This includes checking if it affects the size of tumours, specific blood markers related to prostate cancer (like PSA), and overall general health. They will also explore how the drug might interact with different kinds of prostate cancer cells and whether certain body markers can predict who might benefit most from the treatment. This will help decide if the drug should be studied further in larger trials.

Key takeaways

This study is for men with advanced prostate cancer that is no longer responding to hormone therapy.
It tests a new drug called ODM-208 to see if it is safe and what dose works best.
Researchers will closely monitor your health and try to see if the drug affects your cancer.
You will need to have regular clinic visits, blood tests, urine tests, and scans.
This is an early-stage study, so the drug is not yet widely available.

Who may be eligible?

This study is specifically designed for adult men who have been diagnosed with prostate cancer that has spread to other parts of their body. Your prostate cancer must also be 'castration-resistant', which means it's still growing despite treatments that reduce male hormones.

To be considered for this study, you must be at least 18 years old. There is no upper age limit described for taking part, so men of all adult ages are invited to discuss if they might be suitable.

Other specific medical checks will be done by the study team to make sure it's safe for you to take part and that the study results will be clear. For instance, they'll need to confirm you have a certain level of general health and that you don't have any other serious medical conditions that might make the trial unsuitable 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 an adult male (18 years or older)?
Have you been diagnosed with prostate cancer that has spread?
Is your prostate cancer still growing despite hormone-lowering treatments?
Are you generally well enough to participate in a clinical trial (you will be assessed by the study doctors)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new drug, ODM-208, in tablet form. There are different strengths of the tablet (for example, 5mg, 25mg, 50mg, or 100mg), and the study team will decide which dose you start on. You might also be given a small dose of another medicine called Midazolam at certain times to help researchers understand how ODM-208 acts in the body.

Throughout the study, you'll have regular visits to the clinic. During these visits, the study team will perform various tests to keep a close eye on your health. This includes taking blood and urine samples, checking your blood pressure, heart rate, and temperature, and performing physical examinations and ECGs (heart tracings). Scans like CT, MRI, and bone scans will be used to check how your cancer is responding to the treatment. You will also complete questionnaires about your general well-being.

Because this is an early-stage study, the exact duration of treatment and number of visits can vary. The team will explain the full schedule, including how long you might take the medication and how often you'll need to come in for checks and follow-up. The overall length of time you'd be involved in the study would be made clear before you agree to participate.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as receiving a new treatment that isn't yet widely available, which might help control your cancer. However, as with any new drug, there are potential risks. The main purpose of this study is to investigate safety, so side effects are possible and will be closely monitored. These might range from mild to more serious, and the study team will explain all known or expected risks in detail. It's very important to remember that participating in a clinical trial is always voluntary, and you have the right 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
France
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Unverified
Finland

Common questions

What is 'castration-resistant prostate cancer'?

This means your prostate cancer is still growing even though your body's male hormone levels are very low, usually due to previous hormone-blocking treatments.

What does 'metastatic' mean?

It means the cancer has spread from your prostate to other parts of your body, such as your bones or other organs.

What is ODM-208?

ODM-208 is a new experimental drug being tested to see if it's safe and effective for treating advanced prostate cancer.

Why do I need so many blood tests and scans?

These tests help the doctors carefully check your health, understand how the new drug is working in your body, and see if it's affecting your cancer.

Will I definitely get the new drug?

Yes, if you meet all the criteria and join this study, you will receive ODM-208. There isn't a placebo group in this particular study.