Active not recruitingPHASE3INTERVENTIONAL

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

This study is for men with cancer who are currently taking a medicine called darolutamide (also known as Nubeqa) as part of another clinical trial sponsored by Bayer. The main goal is to allow these patients to continue receiving darolutamide treatment if their doctor believes it is still helping them. Participants will continue with the same dose they were on and will attend regular doctor's visits, just as they did in the previous study. This ensures a consistent approach to their treatment if it's proving beneficial and they meet the study's requirements. It's designed to provide ongoing support for patients who are responding well to the medication.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bayer

Enrolment target

402

Start

20 Oct 2020

Estimated completion

26 Jun 2028

Cancer

What is this study about?

This study, called "Study to Continue Treatment With Darolutamide," is designed to allow certain men with cancer to keep taking a medicine called darolutamide. Darolutamide is also known by its brand name, Nubeqa. This isn't a new study for people who haven't taken the medicine before; instead, it's for those who are already receiving darolutamide in another study supported by Bayer.

The main idea behind this study is to make sure that if darolutamide is helping you, you can continue to receive it without a gap in treatment. Your doctor would need to agree that continuing the medicine is good for you. You'd keep taking the same dose of darolutamide and visit the study doctors as often as you did in your previous study. This helps your care team monitor your health and how well the treatment is working.

Basically, if you're already in a Bayer study taking darolutamide, and it's making a positive difference, this study offers a way to continue that treatment path. It's focused on maintaining your care and ensuring you keep getting the benefits of the medicine as long as your doctor recommends it.

Key takeaways

This study continues existing darolutamide treatment for men with cancer.
It's for those already in a Bayer study who are benefiting from the medicine.
Patients will stay on the same dose and have the same number of doctor visits.
The goal is to provide ongoing treatment if it's considered beneficial by your doctor.
You must be aged 18 or older to participate.

Who may be eligible?

This study is for men who are currently taking darolutamide as part of another Bayer-sponsored trial. You must be benefiting from the treatment and your doctor must believe it's good for you to continue. You should also be willing to use reliable methods of birth control during the study.

There are a few reasons why someone might not be able to join. For example, if you can't follow the study's instructions or if your doctor thinks the risks of continuing the treatment might outweigh the benefits. Also, if you've had to stop treatment in your previous study due to certain reasons, you wouldn't be able to join this one.

Overall, your doctor will carefully consider if this study is the right and safest choice for you. Only men aged 18 or older are eligible.

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 currently taking darolutamide (Nubeqa) in another Bayer-sponsored study?
Does your current doctor believe that continuing darolutamide is good for your health?
Are you 18 years old or older?
Are you able to follow the study's requirements and use birth control if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll continue to take your darolutamide medicine at the same dose you were on in your previous study. You'll also continue to have regular check-ups with the study doctors at the same frequency as before. These visits are important for your care team to see how you're doing and if the medicine is still working well for you. The study aims to provide ongoing treatment for as long as your doctor believes it's beneficial and you meet the study requirements. There isn't a fixed end date like in a typical trial; it continues your existing treatment path.

Potential risks and benefits

The potential benefit of continuing in this study is that you can keep receiving darolutamide, which your doctor believes is helping you. This could mean sustained improvement in your condition. As with any medicine, there can be risks, including further side effects. Your doctor will discuss these with you and constantly weigh whether the benefits of continuing treatment outweigh any potential risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (335)

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

Urology Centers of Alabama, PC - Homewood
Verified postcode
Homewood, United States
Ironwood Cancer and Research Centers - Chandler I
Verified postcode
Chandler, United States
Tower Urology
Verified postcode
Los Angeles, United States
Stanford Cancer Center Palo Alto
Verified postcode
Palo Alto, United States
San Diego Clinical Trials
Verified postcode
San Diego, United States
TOI Clinical Research
Verified postcode
Whittier, United States
Rocky Mountain Regional VA Medical Center - Oncology
Verified postcode
Aurora, United States
The Urology Center Of Colorado
Verified postcode
Denver, United States
Boca Raton Regional Hospital - Oncology
Verified postcode
Boca Raton, United States
Jesse Brown VA Medical Center - Cardiology
Verified postcode
Chicago, United States
Illinois CancerCare - Peoria
Verified postcode
Peoria, United States
Norton Cancer Institute - Downtown
Verified postcode
Louisville, United States

Common questions

What is darolutamide?

Darolutamide is a medicine also known as Nubeqa, used to treat certain types of cancer.

Who is this study for?

This study is for men already taking darolutamide in another Bayer-sponsored study who are doing well and whose doctor thinks they should continue.

Will I take a different dose of darolutamide?

No, you will continue taking the same dose of darolutamide that you are currently on.

How often will I need to visit the doctor?

You will return for doctor's visits as often as you did in your previous study.

Will I receive a different medicine?

No, this study is specifically to continue your treatment with darolutamide, not to switch to a different medicine.