Active not recruitingOBSERVATIONAL

A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide

This study focuses on men with prostate cancer that has spread to other parts of the body (metastatic) and is still sensitive to hormone treatment. The main goal is to understand how two different medicines, apalutamide and enzalutamide, work in real-life situations when added to standard hormone therapy. Researchers want to compare the outcomes for patients receiving either of these treatments. This helps doctors and patients make informed decisions about the best ways to manage this type of prostate cancer.

At a glance

Status

Active not recruiting

Sponsor

Janssen-Cilag Ltd.

Enrolment target

504

Start

05 Jul 2023

Estimated completion

05 Jun 2026

Metastatic Hormone-sensitive Prostate Cancer

What is this study about?

This study is about understanding how treatments for prostate cancer work in everyday situations. If you have prostate cancer that has spread to other parts of your body (doctors call this 'metastatic') but is still affected by hormones (called 'hormone-sensitive'), this study might be relevant to you. Prostate cancer often grows because of male hormones, and treatments that block these hormones are a key part of managing it.

In this study, researchers are looking at two specific medications, apalutamide and enzalutamide. These drugs are often given alongside standard hormone therapy (known as ADT, or androgen deprivation therapy). The main aim is to compare how effective each of these combinations is in helping patients. By looking at real-world patient information, doctors can learn more about which treatment might be best.

This is not a study where you are given a new or experimental drug. Instead, it's about observing and collecting information on treatments that doctors are already prescribing. This kind of research is very helpful because it gives us a better idea of how these treatments truly perform for a wide range of patients, beyond the controlled environment of earlier trials.

Key takeaways

This study helps doctors learn more about common prostate cancer treatments.
It focuses on prostate cancer that has spread but still responds to hormone therapy.
It compares two medicines, apalutamide and enzalutamide, when used with standard hormone therapy.
Participation involves sharing your health information and completing surveys, not experimental treatments.
Your treatment plan won't change because you join the study; you'll receive the care your doctor recommends.

Who may be eligible?

To be considered for this study, you must have been diagnosed with prostate cancer that has spread and is sensitive to hormones. Your doctor must have already decided that you will start taking either apalutamide or enzalutamide, along with your usual hormone therapy, before you join the study.

There are also some things that would mean you can't join. For example, if you've already had apalutamide, enzalutamide, or certain other similar hormone treatments. You also can't join if your cancer has already become resistant to hormone therapy, or if you've been on hormone therapy for this type of prostate cancer for too long before starting apalutamide or enzalutamide.

Quick self-check

I have prostate cancer that has spread.
My prostate cancer is still sensitive to hormone treatment.
My doctor has decided I will start apalutamide or enzalutamide plus hormone therapy.
I have not already received apalutamide, enzalutamide, or certain other similar new hormone treatments.
My cancer has not become resistant to hormone therapy yet.
I haven't been on hormone therapy for this condition for more than 2 months before starting the new drug.

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 in this study, it means you're agreeing to let researchers collect information about your health and treatment. This includes details from your medical records, like your prostate-specific antigen (PSA) levels, especially one taken just before you start your new medication. You will also be asked to fill out surveys about how you are feeling and how your treatment is affecting your daily life. These surveys are called 'patient-reported outcomes' and are an important part of understanding the real-world impact of your treatment. The study will mainly involve collecting information from your routine doctor visits and your own reports, rather than requiring extra study-specific visits.

Potential risks and benefits

Taking part in this study primarily involves allowing researchers to collect and analyse your existing medical data and your personal reports on your health. While there are no direct medical risks from participating, as you would be receiving treatment already prescribed by your doctor, there is a small risk that your personal information, if not properly protected, could be seen by unauthorised people. However, strict measures are in place to keep your data private. The potential benefit is that the information gathered from your experience and many others could help doctors better understand and improve future treatments for prostate cancer. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (53)

Akh Wien
Vienna, Austria
Klinikum Wels Grieskirchen
Wels, Austria
Institut Sainte Catherine
Avignon, France
Institut Bergonie
Bordeaux, France
Polyclinique Bordeaux Nord Acquitaine
Bordeaux, France
Clinique Pasteur- Lanroze
Brest, France
Hopital Michallon CHU Grenoble Alpes
La Tronche, France
Hôpital Edouard Herriot
Lyon, France
Centre d'oncologie de Gentilly
Nancy, France
CHU Nimes
Nîmes, France
Hopital Europeen Georges-Pompidou
Paris, France
Hopital Tenon
Paris, France

+41 more sites — see the official record for the full list.

Common questions

What is 'metastatic hormone-sensitive prostate cancer'?

This means your prostate cancer has spread to other parts of your body, and it still responds to treatments that lower male hormones.

Are the treatments in this study experimental?

No, apalutamide and enzalutamide are approved medicines that doctors already prescribe. This study is observing how well they work in real-life patients.

What is 'standard hormone therapy'?

It's called ADT (androgen deprivation therapy) and it's a common treatment that lowers the amount of male hormones in your body to help control prostate cancer.

Will I have more doctor appointments if I join?

No, joining this study usually doesn't mean extra doctor visits. The researchers will mostly collect information from your regular care.

Can I stop being part of the study once I've joined?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect the care you receive from your doctor.