RecruitingPHASE3INTERVENTIONAL

Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer

This study is for men with prostate cancer that has spread, either newly diagnosed or when it has become resistant to standard hormone treatment. It's looking into special hormone tablets called ARPIs (like Abiraterone, Apalutamide, Enzalutamide, or Darolutamide). The main goal is to see if taking a lower dose (half the usual amount) of these tablets works just as well as the standard dose in controlling the cancer and helping men live longer. An important part of the study is also to check if the lower dose causes less extreme tiredness and fewer reasons for people to stop their treatment. Participants will be given either the standard or a lower dose and will be monitored closely.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University College, London

Enrolment target

1,500

Start

28 Aug 2026

Estimated completion

01 Aug 2033

Prostate Cancer mHSPC mCRPC

What is this study about?

This study is looking for men who have prostate cancer that has spread to other parts of their body. This might be prostate cancer that's been recently diagnosed and has already spread (called mHSPC), or cancer that has spread and has become more difficult to treat with standard hormone therapy (called mCRPC). The main aim is to find out the best way to use some important medicines, which are hormone tablets known as ARPIs (Androgen Receptor Pathway Inhibitors). These include medicines like Abiraterone, Apalutamide, Enzalutamide, or Darolutamide.

The research wants to see if using a lower dose of these hormone tablets (half the usual amount) can be just as good as the standard full dose. Researchers are especially interested in two main things: first, whether men live just as long on the lower dose compared to the full dose, and second, if the lower dose causes less extreme tiredness (fatigue) and fewer side effects that might make someone stop their treatment. If a lower dose works just as well with fewer side effects, it could greatly improve how men feel during their treatment and make the treatment more comfortable.

This study is important because it could help improve the quality of life for men with advanced prostate cancer. By finding out if a lower dose is effective and causes fewer side effects, it could lead to better and more tolerable treatments for many people in the future. The study is planned to follow participants for about three years after treatment, with the final results expected around August 2032.

Key takeaways

This study is for men with prostate cancer that has spread.
It compares a standard dose with a lower dose of hormone tablets called ARPIs.
The goal is to see if a lower dose is as effective but with fewer side effects like tiredness.
Participation involves regular clinic visits, questionnaires, and providing samples.
Taking part could help improve future treatments for prostate cancer.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To take part in this study, you need to be an adult male, aged 18 or older. You must have prostate cancer that has spread to other parts of your body. This includes either newly diagnosed advanced prostate cancer that is still sensitive to hormone treatment, or prostate cancer that has spread and has become resistant to standard hormone therapy. Your doctor must also think that starting one of the special hormone tablets (ARPIs) along with standard hormone therapy is a suitable treatment plan for you.

There are some reasons why you might not be able to join. For example, if you have a different type of prostate cancer (not adenocarcinoma), or if you can't take the standard hormone therapy alongside the study medication. You also wouldn't be eligible if you've had other types of cancer treatment recently (unless it was for very common, easily treated skin cancers or certain bladder cancers), or if you are already on a 'triplet therapy' (which means receiving three different types of cancer treatment at the same time, besides radiotherapy).

If you have serious psychological or social issues that would make it hard to stick to the study plan or give your permission, you wouldn't be able to join. Also, if you've recently taken part in another drug study, or if you have allergies to any of the study medications, you wouldn't be suitable.

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 an adult male (aged 18 or older)?
Do you have prostate cancer that has spread?
Has your doctor planned for you to start ARPI hormone tablets with standard hormone therapy?
Have you *not* had other types of cancer treatment (apart from very common skin/bladder cancers) in the last two years?
Are you able to attend regular appointments and complete questionnaires?
Do you *not* have any allergies to the planned study medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either the full dose or half dose of one of the ARPI hormone tablets (like Abiraterone, Apalutamide, Enzalutamide, or Darolutamide). You will also receive your usual standard hormone therapy (ADT).

You'll be on the study treatment for about three years. You'll have regular check-ups at your hospital clinic, or sometimes remotely, just like you would with your usual care. You won't need extra visits specifically for the study. You will also be asked to fill in questionnaires about your quality of life at the start, and then at 4, 16, 32, 48, and 64 weeks. You'll also be asked to keep a diary of any symptoms you experience.

To help with the research, you'll be asked to provide blood samples at the start, and then at 24, 32, 48 weeks, and if your cancer progresses. Urine samples will be collected at the start, 24 weeks, and if your cancer progresses. We will also use existing tissue samples from your original diagnosis. After you finish treatment, you'll be followed up for around three more years, with the study planning to finish in August 2032.

Potential risks and benefits

Taking part in this study may offer several potential benefits. If the lower dose of medication is found to be as effective as the standard dose, but with fewer side effects like extreme tiredness, it could significantly improve your quality of life during treatment. You would also be contributing to important research that could help many other men with prostate cancer in the future. However, there are also potential risks. The lower dose might not work as well for everyone as the standard dose. All medications carry potential side effects, and while the study aims to reduce these, they cannot be entirely eliminated. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is 'advanced prostate cancer'?

This means prostate cancer that has spread from the prostate gland to other parts of your body.

What are ARPIs?

ARPIs are special hormone tablets (like Abiraterone, Apalutamide, Enzalutamide, or Darolutamide) that work by blocking hormones that help prostate cancer grow.

Will I know if I'm getting the full or half dose?

No, you will be 'randomly assigned' to one dose or the other, and neither you nor your doctor will know which dose you are receiving. This helps make the study fair.

What does 'fatigue' mean?

Fatigue means feeling extremely tired and lacking energy, even after resting. It's a common side effect of cancer and its treatments.

How long will the study last for me?

You will be on treatment for about three years, and then followed up for around another three years, if you stay in the study for the maximum duration.

How to find out more

ENHANCE Trial Manager

ctc.enhance@ucl.ac.uk +44 (0) 207 679 9898 Official trial record

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