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Active not recruitingOBSERVATIONAL

A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described

This study is for men with a type of prostate cancer called non-metastatic castration-resistant prostate cancer (nmCRPC). This means the cancer hasn't spread to other parts of the body, but it's no longer controlled by treatments that lower testosterone. The study aims to see how well darolutamide (also known as Nubeqa) works and how safe it is for these men in a real-world setting. Patients included in this study have already had their doctor decide that darolutamide is the right treatment for them, based on standard medical care. The study will then observe these patients and collect information on their health journey while on darolutamide.

At a glance

Status
Active not recruiting
Sponsor
Bayer
Enrolment target
805
Start
30 Jan 2020
Estimated completion
30 Dec 2026

What is this study about?

This study focuses on prostate cancer that doctors call 'non-metastatic castration-resistant prostate cancer,' or nmCRPC for short. In simpler terms, this means the cancer is still contained within the prostate area and hasn't spread to other parts of the body like bones or other organs. 'Castration-resistant' means that treatments designed to lower male hormones (like testosterone) are no longer fully controlling the cancer.

The main goal of this study is to understand how a medicine called darolutamide (you might know it as Nubeqa) works in everyday medical practice. Researchers want to collect information on how effective it is and if there are any side effects for men with this specific type of prostate cancer. It's important to know that for patients joining this study, the decision to use darolutamide has already been made by their doctor as part of their regular care, before they even join the study.

This isn't a study where participants are given a new or experimental treatment they wouldn't otherwise receive. Instead, it's an 'observational' study. This means researchers are simply observing and gathering information from patients who are already being treated with darolutamide. This helps doctors learn more about how well treatments work for people in real-life situations, outside of very strict clinical trial environments.

Key takeaways

  • The study watches how darolutamide works for prostate cancer that hasn't spread but is resistant to hormone therapy.
  • Patients joining are already prescribed darolutamide by their doctor.
  • It's an 'observational' study; no extra treatments are given for research.
  • Aims to collect real-world information on the medicine's safety and effectiveness.
  • Your medical care is not changed by participating, only monitored.

Who may be eligible?

This study is looking for men aged 18 and over who have a confirmed diagnosis of prostate cancer that has not spread to other parts of the body but is no longer responding to standard hormone treatments. You would typically need to show a continuous rise in a blood marker called PSA, even while on hormone therapy.

To join, your doctors must have already decided that darolutamide is the right treatment for you, based on their usual practice. You would also need to have imaging scans that confirm your cancer has not spread. If you've been on similar hormone-blocking medicines like enzalutamide or apalutamide before, there are specific rules about how long you used them and whether any side effects have settled.

You wouldn't be able to join if you're taking part in another study with experimental treatments, if darolutamide isn't suitable for you based on its instructions, or if you've already taken darolutamide for more than three days before deciding to join this study. Also, if you had a very long previous treatment (over a year) with enzalutamide or apalutamide, you would not be 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.

  1. Are you a man over 18?
  2. Do you have prostate cancer that hasn't spread?
  3. Has your cancer stopped responding to typical hormone treatments?
  4. Has your doctor already decided that darolutamide is the best treatment for you?
  5. Do you have a life expectancy of at least 3 months?
Answer every question to see your result.

What does participation involve?

Because this is an 'observational' study, taking part mainly involves allowing researchers to collect information from your existing medical records and during your routine doctor's appointments. You won't be given any extra medicines or treatments specifically for the study itself; you'll receive your darolutamide as prescribed by your doctor. The study will track your health outcomes, such as your PSA levels, how you're feeling, and any side effects, over a period of time. The total duration of your participation would depend on your individual treatment plan and how long your doctor determines you should stay on darolutamide.

Potential risks and benefits

Participating in this study means doctors can gather valuable information about how darolutamide works for patients just like you in everyday care. While there are no direct medical benefits from simply being in the study, your contribution helps improve understanding of this treatment for future patients. The risks involved are generally minimal since you're already receiving darolutamide as part of your standard care; the main change is that your health information will be collected for research. You always have the right to withdraw from the study at any time without it affecting your medical care.

Locations (41)

  • Urology Centers of Alabama
    Verified postcode
    Homewood, United States
  • Arizona Institute of Urology
    Verified postcode
    Tucson, United States
  • Genesis Comprehensive Prostate Cancer Center
    Verified postcode
    San Diego, United States
  • The Urology Center of Colorado
    Verified postcode
    Denver, United States
  • Manatee Medical Research Institute
    Verified postcode
    Bradenton, United States
  • Advanced Urology Institute
    Verified postcode
    Daytona Beach, United States
  • Research by Design, LLC
    Verified postcode
    Chicago, United States
  • First Urology, PSC
    Verified postcode
    Jeffersonville, United States
  • Wichita Urology Group
    Verified postcode
    Wichita, United States
  • Southcoast Centers for Cancer Care
    Verified postcode
    Fairhaven, United States
  • New Jersey Urology
    Verified postcode
    Englewood, United States
  • Beacon Cancer Care
    Verified postcode
    Beacon, United States

Common questions

What is 'nmCRPC'?

It means prostate cancer that hasn't spread to other parts of your body, but it's no longer fully controlled by hormone treatments.

Is darolutamide a new or experimental medicine?

No, darolutamide (Nubeqa) is an approved medicine. This study is observing how it works in real-life use.

Do I have to take any extra medicines for this study?

No, you will only receive darolutamide if your doctor has already decided it's the right treatment for you, as part of your usual care.

Will joining this study change my medical care?

No, your medical care will remain exactly the same as decided by your doctor. The study only involves collecting information from your existing care.

What happens if I decide I don't want to be in the study anymore?

You can withdraw at any time without giving a reason, and it won't affect your ongoing medical treatment.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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