RecruitingOBSERVATIONAL

A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France

This study focuses on men in France who have a specific form of prostate cancer called metastatic hormone-sensitive prostate cancer (mHSPC). They are being treated with a medication called apalutamide, along with other standard treatments. The main goal is to understand how well these men take their apalutamide medication over the first year of treatment. Researchers also want to figure out why some men might miss doses or stop taking their medicine. By looking at different aspects of a man's health and lifestyle, the study aims to identify what factors might make it harder to stick to the treatment plan. This information could help doctors better support patients in taking their medication correctly.

At a glance

Status

Recruiting

Sponsor

Janssen Cilag S.A.S.

Enrolment target

270

Start

18 Dec 2025

Estimated completion

03 Jan 2028

Prostatic Neoplasms Metastatic Hormone-sensitive Prostate Cancer

What is this study about?

This study is designed to learn more about how men with a particular type of prostate cancer, called metastatic hormone-sensitive prostate cancer (mHSPC), manage their medication. mHSPC means the cancer has spread to other parts of the body, but it still responds to treatments that target hormones. The focus is on a specific drug called apalutamide, which is often used alongside other hormone therapy. The researchers want to see how consistently men take apalutamide during the first year of their treatment. This is important because taking medication as prescribed is key for it to work effectively.

The study also aims to understand *why* some men might not take their medication exactly as their doctor advised. This could be for many reasons, like forgetting, side effects, or other personal circumstances. By looking at different details about the men taking part, such as their background and how they feel about their treatment, the study hopes to find patterns. This information will help doctors and nurses better support men with prostate cancer to stick to their treatment plans.

Ultimately, the goal is to improve how patients receive their full treatment. If we understand the challenges men face in taking their medication, we can develop better ways to help them. This could lead to more successful treatments and better health outcomes for men living with mHSPC.

Key takeaways

This study helps understand how men take their prostate cancer medication.
It focuses on apalutamide for metastatic hormone-sensitive prostate cancer.
Participation involves filling out questionnaires about your medication use.
The study aims to improve support for patients taking their prescribed drugs.
You won't receive new treatments or extra visits beyond your usual care.
Your private information will be protected.

Who may be eligible?

To join this study, you must be a man aged 18 or older who has been diagnosed with prostate cancer that has spread (metastatic) and still responds to hormone treatment. You should have already decided with your doctor to start taking apalutamide, along with other standard hormone therapy, before joining the study.

Your doctor would need to confirm your specific type of prostate cancer. You must also be able to understand information about the study and agree for your health information to be collected. Before starting apalutamide, there should be a record of your PSA (prostate-specific antigen) level. You must also be willing to fill out questionnaires about how you're taking your medication and your quality of life during the study.

You wouldn't be able to join if you've already taken apalutamide or similar prostate cancer drugs, or had certain other treatments recently. You also can't be in another prostate cancer study that involves a new drug or device. If you've had certain hormone treatments for your prostate cancer for more than 4 months before taking apalutamide, or if your cancer has become resistant to hormone therapy before starting apalutamide, you also wouldn't be eligible. Lastly, you need to be able to speak and read French to take part.

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 a man aged 18 or older?
Do you have metastatic hormone-sensitive prostate cancer?
Have you started, or are you about to start, apalutamide with other hormone therapy?
Are you able to understand study information and fill out questionnaires?
Do you speak and read French?
Have you not previously taken apalutamide or similar prostate cancer drugs?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll continue with your usual apalutamide treatment as prescribed by your doctor. The main part of your involvement will be completing questionnaires. You'll fill out surveys about how you're taking your apalutamide medication and how it affects your daily life and well-being. You'll complete these questionnaires at different points during the first year of your treatment, including one before you start taking apalutamide for the study.

The study will also gather information from your medical records, such as your PSA levels. There are no extra hospital visits required specifically for this study beyond your regular doctor's appointments. The total duration of your participation in collecting information through questionnaires will be over your first year of continued apalutamide treatment.

Potential risks and benefits

Taking part in this study means your personal health information will be collected, but it will be kept private. While there's no new medication or treatment involved beyond what your doctor has already prescribed, the main benefit is helping researchers understand how best to support men like you in taking their vital medication. This could lead to improvements in patient care in the future. There are no major new risks associated with this study, as you would be taking apalutamide regardless. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Centre Francois Baclesse
Verified postcode
Caen, France· Recruiting

Common questions

What is metastatic hormone-sensitive prostate cancer?

This is prostate cancer that has spread to other parts of the body but still responds to treatments that lower male hormones.

What is apalutamide?

Apalutamide is a medication used to treat prostate cancer by blocking certain hormone signals that cancer cells need to grow.

Will I receive any new treatment in this study?

No, you will receive the apalutamide treatment already decided by your doctor; this study just observes how you take it.

How long will I be in the study?

Your involvement in providing information for the study will last for the first year of your apalutamide treatment.

Will my information be kept private?

Yes, all your personal and health information collected for the study will be kept confidential.

How to find out more

Study Contact

participate-in-this-study1@its.jnj.com 844-434-4210 Official trial record

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