Active not recruitingOBSERVATIONAL

A Study to Learn How Men With Advanced Prostate Cancer Respond to Treatment With Darolutamide and Hormone Therapy, With or Without Chemotherapy, in Real-world Medical Practice

This international study is observing how men with advanced prostate cancer (specifically, metastatic hormone-sensitive prostate cancer, or mHSPC) are treated with a combination of darolutamide and hormone therapy, sometimes including chemotherapy. We want to see how effective and safe this treatment approach is in everyday medical practice across various clinics. The study will enrol about 1,600 men and will track how many achieve very low PSA levels after a year. We'll also look at things like how long patients live, how their quality of life is, and any side effects. This helps doctors better understand how to use these treatments and what patients can expect.

At a glance

Status

Active not recruiting

Sponsor

Bayer

Enrolment target

1,600

Start

29 Jan 2026

Estimated completion

30 Jun 2030

Metastatic Hormone-Sensitive Prostate Cancer

What is this study about?

This study is about understanding how a treatment called darolutamide works in men who have advanced prostate cancer that has spread to other parts of the body (this is called metastatic) but still responds to hormone therapy. Doctors call this 'metastatic hormone-sensitive prostate cancer' (mHSPC). The study is designed to watch how this treatment is used in real life, rather than in a highly controlled research environment. It will observe patients who are already going to be treated with darolutamide, along with standard hormone therapy, and sometimes chemotherapy (docetaxel).

The main goal is to see how many patients achieve very low levels of Prostate-Specific Antigen (PSA) – a marker that doctors use to monitor prostate cancer – after one year of treatment. Achieving a very low PSA often indicates that the treatment is working well. The study will also look at how long patients live, how long it takes for their cancer to start growing again, and whether they need to switch to new treatments. It will also gather information on any side effects patients experience and how the treatment affects their quality of life.

By collecting all this information from many different hospitals and clinics, the study hopes to provide a clearer picture of how darolutamide is used in the UK and other countries, what its benefits and potential downsides are in a wide range of patients, and how it impacts people's lives. This will help doctors make the best treatment choices for their patients moving forward. No extra tests or procedures are required beyond what your doctor would normally recommend.

Key takeaways

Observational study, no extra treatments or procedures.
Investigates darolutamide for advanced prostate cancer.
Aims to understand treatment effectiveness and safety in real-life settings.
Data collected from routine medical care.
Helps improve understanding for future patient care.
Participation is voluntary and can be withdrawn at any time.

Who may be eligible?

To join this study, you must be a man aged 18 or older with a specific type of advanced prostate cancer that has spread to other parts of your body. This cancer must have been confirmed by a doctor through a biopsy, and you should be about to start treatment with darolutamide, either alone or with chemotherapy (docetaxel), as decided by your doctor.

You also need to be well enough to expect to live for at least three more months, according to your doctor's judgment. Importantly, you cannot have already received certain other types of prostate cancer drugs that are similar to darolutamide, and your darolutamide treatment must not have started more than 7 days before you join the study. If you're currently in another research study that involves new treatments, you wouldn't be able to join this one.

Quick self-check

Am I a man aged 18 or over?
Do I have advanced prostate cancer that has spread?
Has my doctor decided I will start darolutamide treatment (with or without chemotherapy)?
Have I started darolutamide less than 7 days ago, or not yet?
Have I not received certain other similar prostate cancer drugs previously?
Am I not currently involved in another medical study requiring new treatments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you won't need to do anything extra beyond what your doctor would normally recommend for your treatment. This is an 'observational' study, meaning that researchers will simply collect information from your routine medical appointments, tests, and scans. You'll continue to receive your darolutamide and hormone therapy (and possibly chemotherapy) as prescribed by your doctor. There are no additional study visits or medications. The study will follow you over time as part of your normal care, and your medical information will be recorded securely. You'll need to sign a consent form to agree for your information to be used for the study.

Potential risks and benefits

The potential benefit of participating is knowing that your health information will contribute to a better understanding of how darolutamide works for men with advanced prostate cancer. This could help doctors make more informed decisions for future patients. There are no direct medical benefits to you from participating, as you will receive the exact same care whether you join the study or not. There are no additional risks to your health by taking part, as no extra procedures or treatments are involved. You are free to withdraw from the study at any time without affecting your medical care.

Locations (16)

Many Locations
Multiple Locations, Belgium
Many Locations
Multiple Locations, Finland
Many Locations
Multiple Locations, France
Many Locations
Multiple Locations, Germany
Many Locations
Multiple Locations, Greece
Many Locations
Multiple Locations, Israel
Many Locations
Multiple Locations, Italy
Many Locations
Multiple Locations, Lithuania
Many Locations
Multiple Locations, Norway
Many Locations
Multiple Locations, Poland
Many Locations
Multiple Locations, Portugal
Many Locations
Multiple Locations, Saudi Arabia

+4 more sites — see the official record for the full list.

Common questions

What kind of cancer is this study looking at?

This study is for men with advanced prostate cancer that has spread to other parts of the body and still responds to hormone therapy. Doctors call this 'metastatic hormone-sensitive prostate cancer'.

Will I get new medicine if I join the study?

No, this study just observes the treatment you're already going to receive as part of your routine medical care. You won't get any new medicines or treatments because of the study.

What is 'real-world' medical practice?

This means the study is looking at how treatments work in everyday clinics and hospitals, rather than in a specially controlled research environment. It reflects what actually happens in patient care.

What kind of information will the study collect?

The study will collect information about your PSA levels, other tests your doctor orders, details about your treatment, any side effects you experience, and how you're feeling overall. All this comes from your routine medical records.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, and it will not affect the care you receive from your doctor.