Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

(21140 ARANOTE) A randomized, double-blind, placebo-controlled Phase 3 study of darolutamide in addition to androgen deprivation therapy (ADT) versus placebo plus ADT in men with metastatic hormone-sensitive prostate cancer (mHSPC).

This research study is for men who have prostate cancer that has spread to other parts of their body but still responds to hormone treatment. Doctors call this 'metastatic hormone-sensitive prostate cancer'. The study is testing a new medicine called darolutamide. Participants will receive either darolutamide or a placebo (a dummy pill with no active medicine), alongside their usual hormone therapy. The main goal is to see if darolutamide can stop the cancer from growing or spreading further for longer. Researchers will also look at how long men live, how long it takes for the cancer to become resistant to hormone therapy, and if darolutamide helps with pain. This is a Phase 3 study, meaning the drug has already shown promise in earlier tests.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Bayer Consumer Care AG, Bayer AG

Enrolment target

132

Start

20 May 2023

Metastatic hormone-sensitive prostate cancer (mHSPC)

What is this study about?

This study is a clinical trial looking at a new medicine called darolutamide for men with a specific type of prostate cancer. This type is called 'metastatic hormone-sensitive prostate cancer'. 'Metastatic' means the cancer has spread from the prostate to other parts of the body. 'Hormone-sensitive' means the cancer still responds to treatments that lower male hormones (like testosterone), which can help slow its growth.

In this study, some men will receive darolutamide along with their regular hormone therapy, while others will get a placebo (a pill that looks the same but contains no active medicine) alongside their hormone therapy. This comparison helps doctors understand if darolutamide is truly effective. The main thing the researchers want to find out is whether darolutamide can prevent the cancer from growing or spreading further for a longer period. They will do this by taking regular scans.

Why does this matter? Finding new and effective treatments for prostate cancer is very important. If darolutamide proves to be successful, it could offer a new option for men living with this condition, potentially improving their quality of life and how long they live without their cancer getting worse. This is a 'Phase 3' study, which means it's one of the final steps before a new medicine might be approved for wider use.

Key takeaways

This study tests a new drug, darolutamide, for prostate cancer that has spread and still responds to hormone therapy.
It compares darolutamide with standard hormone treatment versus a placebo with standard hormone treatment.
The main aim is to see if darolutamide can stop the cancer from getting worse for longer.
Participants will have regular check-ups, blood tests, and scans.
The study involves a 'double-blind' approach, meaning you won't know if you're on the active drug or placebo.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

This study is specifically looking for men who have prostate cancer that has spread to other parts of their body. Importantly, their cancer must still be responding to hormone therapy, meaning treatments that lower male hormones are still effective in keeping the cancer in check. This is sometimes called 'metastatic hormone-sensitive prostate cancer'.

To join, participants must be at least 18 years old. There is no upper age limit for taking part, as long as you meet the other health criteria. The study is only open to men.

Before joining, doctors will carefully check your overall health and your specific cancer details to make sure the study is a good fit for you. This helps ensure your safety and that the study results are clear.

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 aged 18 or older?
Do you have prostate cancer that has spread to other parts of your body?
Does your prostate cancer still respond to hormone treatments?
Are you able to take daily medication by mouth?
Are you willing and able to attend regular clinic appointments for tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new study drug (darolutamide) or a placebo (a dummy pill) by mouth, every day. You would also continue to receive your standard hormone therapy for prostate cancer. You won't know whether you are receiving the active drug or the placebo, and neither will your doctor, until the study is over. This is called 'double-blind' and helps ensure the results are fair.

Throughout the study, you would have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how your cancer is responding. These visits are important for tracking your progress and checking for any side effects. The exact number and timing of visits would be explained to you in detail by the study team. You would be in the study for several years, or until your cancer progresses or you decide to stop participating. After the main treatment period, there would also be follow-up appointments to track your long-term health.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. A potential benefit of this study is that if you receive darolutamide, it might help control your prostate cancer for longer than hormone therapy alone, and potentially extend your life. However, there's also a chance you could receive the placebo, which would not offer these potential benefits from the study drug itself. All medications, including darolutamide, can have side effects, which might include anything from mild discomfort to more serious reactions, although the study team will monitor you closely for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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
Latvia
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Unverified
Lithuania

Common questions

What is 'metastatic hormone-sensitive prostate cancer'?

This is prostate cancer that has spread to other parts of your body, but it still responds well to treatments that lower male hormones.

What is darolutamide?

Darolutamide is a new medicine being tested. It's a type of anti-androgen, meaning it works by blocking the effects of male hormones that can make prostate cancer grow.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study drug but contains no active medicine. It's used to compare against the real drug to see if the drug is truly effective.

Will I know if I'm getting the real drug or the placebo?

No, neither you nor your doctor will know if you're getting darolutamide or the placebo during the study. This is called 'double-blind' and helps ensure the study results are accurate.

How long will the study last?

The active treatment phase of the study could last for several years, and there will be follow-up visits after that to monitor your long-term health.