Active not recruitingOBSERVATIONAL

Impact of Apalutamide in Metastatic Hormone Sensitive Prostate Cancer Patients

The ADAPT study is for men with prostate cancer that has spread and is sensitive to hormones. It focuses on a treatment called apalutamide, which doctors might suggest. If your doctor thinks apalutamide is right for you, and you agree to take it, then you might be asked to join this study. The main goals are to see how well apalutamide works based on blood tests (PSA levels) and to understand its impact on your quality of life, including energy levels and thinking. This is done by asking you to fill out questionnaires over time. This research helps us learn more about how treatments work in everyday life, not just in very controlled studies, to improve care for future patients.

At a glance

Status

Active not recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

170

Start

26 Sep 2023

Estimated completion

01 Apr 2027

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

What is this study about?

Imagine you have prostate cancer that has spread to other parts of your body, but it's still sensitive to hormone treatments. Your doctor might suggest a medicine called apalutamide. The ADAPT study is like a special observation project that watches how this medicine works for people just like you, in real-world situations, rather than in a highly controlled hospital setting.

This study isn't testing whether apalutamide works — that's already known. Instead, it's about gathering more information on its effects when used in everyday medical care. Researchers want to understand two key things: first, how well the medicine is working inside your body, which they check with a regular blood test called PSA. Second, they want to know how it affects your daily life, your energy levels, your ability to think clearly, and your overall well-being. This is where you come in, by answering questionnaires about how you're feeling.

Why is this important? Most of what we know about medicines comes from big, strict studies where only certain people can take part. While these studies are crucial, they don't always fully show how a medicine works for everyone in the real world. The ADAPT study helps fill this gap, giving doctors a clearer picture of apalutamide's benefits and any side effects for a wider range of patients like you. This information helps improve care for all men with prostate cancer.

Key takeaways

The study observes how apalutamide works for men with prostate cancer that has spread.
Participation involves taking your prescribed apalutamide and answering questionnaires.
It helps doctors understand real-world effectiveness and impact on quality of life.
Your regular PSA blood tests will provide important information for the study.
You can withdraw at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you would need to be a man aged 18 or older. You must have prostate cancer that has been confirmed by a lab test, and it needs to be of a type that has spread to other parts of your body (metastatic) and is sensitive to hormone treatment. A key point is that your doctor must have already decided that apalutamide is the right treatment plan for you.

There are also some reasons why you wouldn't be able to join. For instance, if your prostate cancer hasn't spread, or if you've already had certain other treatments like chemotherapy, or specific medications for prostate cancer (including apalutamide itself, or similar drugs like abiraterone, darolutamide, or enzalutamide). Also, if you find it difficult to complete questionnaires about your health, you wouldn't be able 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 over?
Do you have prostate cancer that has spread to other parts of your body?
Has your doctor decided that apalutamide is the right treatment for you?
Have you not had certain other prostate cancer treatments in the past (like chemotherapy or similar drugs)?
Are you able to fill out questionnaires about your health?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be taking apalutamide as your doctor prescribed, just as you would normally. The main activities for the study will involve answering some questionnaires about your health and how you're feeling. These questions will cover things like your energy levels, how clearly you're thinking, and your general quality of life. You'll receive these questionnaires by email or post at specific times: 12, 24, 36, 48, 72, and 104 weeks after you start taking apalutamide. This means the study will follow you for about two years from when you begin your treatment. Your regular blood tests for PSA (which your doctor already monitors) will also be used to track how the medicine is working.

Potential risks and benefits

Taking part in this study doesn't change the treatment you receive; you'll still be getting apalutamide which your doctor has recommended as part of your care. The potential benefit is that your experiences will contribute to valuable knowledge that helps doctors better understand how apalutamide works in everyday situations, ultimately improving care for others. The main commitment for you is filling out questionnaires periodically. There are no additional medical risks beyond those already associated with taking apalutamide itself, which your doctor will discuss with you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Royal Marsden Hospital
Verified postcode
Sutton, United Kingdom
Buckinghamshire Healthcare NHS Trust
Verified postcode
Aylesbury, United Kingdom
Northern Ireland Cancer Centre, Belfast Health & Social Care Trust
Verified postcode
Belfast, United Kingdom
East Lancashire Hospitals NHS Trust
Verified postcode
Blackburn, United Kingdom
Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom
Velindre Cancer Centre, Velindre University NHS Trust
Verified postcode
Cardiff, United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust
Verified postcode
Lancaster, United Kingdom
Clatterbrdige Cancer Centre, NHS Foundation Trust
Verified postcode
Liverpool, United Kingdom
The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust
Verified postcode
Middlesbrough, United Kingdom
South Tyneside and Sunderland NHS Foundation Trust
Verified postcode
Newcastle, United Kingdom
Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust
Verified postcode
Newcastle, United Kingdom
The University Hospital of North Tees
Verified postcode
Stockton-on-Tees, United Kingdom

Common questions

What is the main goal of this study?

The study aims to see how apalutamide works in real-life for men with prostate cancer, by looking at blood test results and how it affects their daily lives.

Do I have to take a new medicine if I join?

No, you only join if your doctor has already decided that apalutamide is the right treatment for you. You'd be taking it anyway, so the study doesn't change your prescribed medicine.

What will I need to do if I participate?

You'll be asked to fill out some questionnaires about how you're feeling and your quality of life at different times over a two-year period.

Will joining this study change my medical care?

No, your medical care and the treatment you receive will be exactly the same whether you join the study or not. Your doctor will still make all treatment decisions.

Can I stop participating in the study later if I change my mind?

Yes, you can choose to stop being part of the study at any time, and this will not affect your medical treatment or care.