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Active not recruitingOBSERVATIONAL

An Observational Study to Learn More About Treatment Patterns and Factors Determining the Choice of Treatment in Canadian Men With Metastatic Hormone Sensitive Prostate Cancer in Routine Medical Care

This study aims to understand how prostate cancer, when it has spread but still responds to hormone treatment, is managed in Canadian men. It's an 'observational' study, meaning researchers simply collect information from existing medical records. They won't ask participants to change their treatment or offer any medical advice. The goal is to learn more about the different treatments doctors choose and why, for men with this specific type of prostate cancer. This includes looking at common hormone therapies and other treatments like ARPi and docetaxel, which help control cancer growth. By understanding current practices, researchers hope to improve future care for patients.

At a glance

Status
Active not recruiting
Sponsor
Bayer
Enrolment target
700
Start
28 Feb 2025
Estimated completion
31 Dec 2026

What is this study about?

This study is designed to help us understand more about how doctors treat prostate cancer that has spread to other parts of the body (this is called 'metastatic' prostate cancer) and still responds to hormone treatment (this is called 'hormone-sensitive'). Many men with prostate cancer are treated with medicines that lower the male hormone testosterone, which can slow down cancer growth. This is known as ADT.

Sometimes, other medicines like ARPi (Androgen Receptor Pathway Inhibitors) or docetaxel are added to ADT to help control the cancer even more. ARPi medicines work by stopping other male hormones from helping cancer cells grow, while docetaxel is a type of chemotherapy that stops cancer cells from multiplying. All these treatments are approved and used routinely in Canada for men with this type of prostate cancer.

The study will look at information already collected by doctors from men who are currently receiving treatment as part of their regular care. The aim is to see which treatments are being used, how they are given, and what might influence a doctor's decision. This kind of research is important because it helps improve our understanding of real-world treatment choices and can eventually lead to better care for patients in the future.

Key takeaways

  • This study helps understand real-world prostate cancer treatment.
  • It's an 'observational' study, using existing medical records.
  • Your medical care and treatments will not change if you participate.
  • The focus is on men with metastatic hormone-sensitive prostate cancer.
  • Data collected will help improve future patient care.
  • Participation involves no direct physical risks.

Who may be eligible?

To be part of this study, you need to be a man aged 18 or older with prostate cancer that has spread to other parts of your body. Doctors must have confirmed this spread with scans, and also confirmed the type of cancer with a biopsy. You also need to have been diagnosed at least six months ago, unless you sadly passed away sooner.

There are a few reasons why you might not be able to join. For example, if you've been on a certain hormone treatment (ADT) for more than six months, or if you've ever used specific newer hormone-blocking medicines called ARPi, you likely won't be eligible. This is because the study wants to focus on prostate cancer that is still hormone-sensitive.

Also, if you are currently taking part in another clinical trial, you wouldn't be able to join this one. Your doctor will be able to check all these details to see if this study is right for you.

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 male and at least 18 years old?
  2. Do you have prostate cancer that has spread to other parts of your body?
  3. Has your cancer been confirmed by a doctor with scans and a biopsy?
  4. Have you been diagnosed with prostate cancer at least 6 months ago?
  5. Have you *not* been on ADT hormone treatment for more than 6 months continuously?
  6. Have you *not* used ARPi medicines (like apalutamide) before?
Answer every question to see your result.

What does participation involve?

If you take part in this study, you won't need to do anything extra or change your current medical care. This is an 'observational' study, which means researchers will only collect information from your existing medical records. You won't receive any new medicines or treatments as part of the study, and you won't have any extra appointments or assessments. Your doctor will continue to treat you as they normally would. The study will look at your treatment and health information over time.

Potential risks and benefits

Because this study only involves collecting information from your existing medical records, there are no direct medical risks to you. You won't receive experimental treatments or undergo extra procedures. The potential benefit is that the information gathered from your records, along with many others, will help researchers understand how prostate cancer is treated in real life. This knowledge can contribute to improving care for future patients. You have the right to withdraw your permission for your data to be used at any time, without affecting your medical treatment.

Locations (1)

  • Pentavere
    Verified postcode
    Toronto, Canada

Common questions

What is 'metastatic hormone-sensitive prostate cancer'?

This means prostate cancer that has spread to other parts of the body, but it still responds to treatments that lower male hormones like testosterone.

Will my treatment change if I join this study?

No, your treatment will not change. This study only collects information from your existing medical records; it does not involve new treatments or medical advice.

What kind of treatments will the study look at?

The study will look at common hormone treatments (ADT), as well as other medicines like ARPi (e.g., apalutamide, darolutamide, enzalutamide) and docetaxel, which are used to treat this type of prostate cancer.

Do I need to visit a special clinic for this study?

No, you do not need to visit a special clinic. All information will be gathered from your existing medical notes and appointments that are already part of your usual care.

Is this study only for Canadian men?

Yes, this particular study is focused on Canadian men and collects data from their medical care within Canada.

How to find out more

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

Discussion

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