Active not recruitingPHASE3INTERVENTIONAL

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

This research is investigating a new medication called darolutamide given alongside usual care for men with prostate cancer. The standard treatments include radiotherapy (X-ray treatment) and hormone therapy (which lowers male hormones that can fuel cancer growth). This specific study focuses on men whose prostate cancer is considered to be at a very high risk of returning or spreading. Researchers want to find out if adding darolutamide helps to make these treatments more effective. The main goals are to see if it can prevent the cancer from spreading to other parts of the body (known as metastases) and ultimately help men live longer, healthier lives. It's a phase 3 study, meaning it's a large trial testing a promising treatment that has already shown good results in earlier stages.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

University of Sydney

Enrolment target

1,100

Start

31 Mar 2020

Estimated completion

31 Jul 2028

Prostate Cancer

What is this study about?

This study is about finding better ways to treat prostate cancer that is considered 'very high-risk'. This means the cancer is more likely to come back or spread after initial treatment. The researchers are looking at a drug called darolutamide, which is a type of hormone treatment. It works by blocking certain signals that prostate cancer cells need to grow.

Currently, men with very high-risk prostate cancer usually receive treatments like radiotherapy (targeting the cancer with high-energy rays) and hormone therapy, which reduces the amount of male hormones in the body that can make prostate cancer grow. This study is testing whether adding darolutamide to these existing standard treatments can improve their effectiveness. They particularly want to see if it can stop the cancer from spreading to other parts of the body, which is a serious complication of prostate cancer.

The hope is that by adding darolutamide, it could help eliminate any tiny cancer cells that might have already spread but are too small to be seen ('micrometastatic disease'). Preventing these cells from growing into larger, detectable cancers could significantly improve the chances of men living longer and healthier lives without their cancer returning or spreading.

Key takeaways

This study is for men with very high-risk prostate cancer.
It tests adding a new drug, darolutamide, to standard radiotherapy and hormone therapy.
The aim is to prevent cancer spread and improve long-term survival.
Participants will receive either darolutamide or a dummy pill.
Joining involves regular check-ups and blood tests.

Who may be eligible?

To join this study, you need to be an adult man, aged 18 or older, who has been diagnosed with prostate cancer. The study is specifically for those whose prostate cancer is considered to be at a very high risk of coming back or spreading.

This might apply to you if you are planning to have radiotherapy for prostate cancer and your doctors consider your cancer to be very high-risk based on specific features like its 'Grade Group' (how aggressive it looks under a microscope), how large the tumour is, or if there's any sign of it in your lymph nodes. It also includes men who have had surgery to remove their prostate within the last year and whose PSA (a blood test marker for prostate cancer) has started to rise again, indicating a high risk of the cancer returning.

Apart from your prostate cancer diagnosis, you'd also need to be generally well enough to take part. This means having healthy blood counts (like haemoglobin, white blood cells, and platelets), and your liver and kidney function need to be working within certain healthy limits according to blood tests. The study is only for men.

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, diagnosed with prostate cancer?
Has your doctor told you that your prostate cancer is at 'very high risk' of returning or spreading?
Are you planning to receive radiotherapy for your prostate cancer, or have you had surgery recently and your PSA is rising?
Are you generally well enough to participate, with healthy blood, liver, and kidney function?
Are you able to attend regular clinic visits and take medication as prescribed?

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 drug, darolutamide, or a placebo (a dummy pill that looks the same but contains no active drug). You would take this alongside your standard treatments, which include hormone therapy given as an injection (called a LHRH Analog) and radiotherapy. You might also receive another standard chemotherapy drug called docetaxel if it's considered suitable for you.

Throughout the study, you would have regular visits to the clinic for medical check-ups, blood tests to monitor your health and the cancer, and to assess how you're feeling. The study treatment period, combining the various therapies, would involve taking the study medication for a while. The total duration of your participation, including follow-up appointments to track your progress long-term, hasn't been specified in detail but would typically last for several years to see the full benefits of the treatment.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. The potential benefit of this study is that adding darolutamide to your current treatment could be more effective at stopping your prostate cancer from returning or spreading, potentially helping you live longer. However, there's no guarantee, and it might not work for everyone. Potential risks include side effects from the study drug, darolutamide, as well as from the standard treatments you would be receiving. While darolutamide is thought to have fewer side effects that affect the brain, any medication can cause unwanted reactions. Before joining, the study team will explain all known side effects. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (93)

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

Dana-Farber Cancer Institute
Verified postcode
Boston, United States
Dana Farber Cancer Institute - St. Elizabeth's
Verified postcode
Brighton, United States
Lahey Hospital and Medical Center
Verified postcode
Burlington, United States
Dana Farber Cancer Institute - Milford
Verified postcode
Milford, United States
XCancer Omaha/Urology Cancer Center
Verified postcode
Omaha, United States
Memorial Sloan Kettering Basking Ridge
Verified postcode
Basking Ridge, United States
New Jersey Urology Saddle Brook
Verified postcode
Clifton, United States
Memorial Sloan Kettering Monmouth
Verified postcode
Middletown, United States
Memorial Sloan Kettering Bergen
Verified postcode
Montvale, United States
New Jersey Urology Voorhees
Verified postcode
Voorhees Township, United States
New Mexico Oncology and Hematology Specialists
Verified postcode
Albuquerque, United States
Memorial Sloan Kettering Commack
Verified postcode
Commack, United States

Common questions

What is darolutamide?

Darolutamide is a drug that helps block male hormones from reaching prostate cancer cells, which can slow down or stop their growth.

What is meant by 'very high-risk' prostate cancer?

This means your cancer has certain features that make it more likely to grow or spread quickly. Your doctor will explain if this applies to you.

Will I definitely get the new drug?

This is a 'randomised' study, meaning you will either receive darolutamide or a placebo (a dummy pill), decided by chance, alongside your usual care.

How long would I be in the study?

While the treatment part involves taking medication for a set period, the follow-up to see how you do long-term could last for several years.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any time, and this will not affect your relationship with your doctors or your future medical care.