Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Randomised phase 3 trial of enzalutamide in androgen deprivation therapy with radiation therapy for high risk, clinically localised, prostate cancer: ENZARAD

This clinical trial, called ENZARAD, is testing a new way to treat prostate cancer that hasn't spread but is considered high-risk. Doctors are trying out a drug called enzalutamide alongside the usual hormone therapy and radiation. The main goal is to see if this combination helps stop the cancer from spreading to other parts of the body, which is called metastasis. They will also look at how long people live, how long they stay free of cancer progression, and if the treatment affects their quality of life. The study aims to find out if this new approach is more effective and safe for men with this type of prostate cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Cancer Trials Ireland

Enrolment target

Start

24 Sep 2024

Localised prostate cancer at high risk of recurrence

What is this study about?

This study is called ENZARAD, and it's looking into a new treatment approach for men with prostate cancer. Specifically, it's for men whose prostate cancer hasn't spread to other parts of their body, but doctors believe it has a high chance of coming back or spreading in the future. This type of cancer is often called 'high-risk localised prostate cancer.'

The main idea behind this trial is to see if adding a particular drug, called enzalutamide (which you might know as Xtandi), to the standard treatment makes a difference. The standard treatment for this condition usually involves hormone therapy and radiation. Hormone therapy works by blocking the hormones that prostate cancer needs to grow. Enzalutamide is another type of hormone treatment that works in a slightly different way. Researchers want to understand if combining all these treatments is better than the standard approach alone.

The most important thing the doctors want to find out is if this new combined treatment can prevent the cancer from spreading to other parts of the body. They will also be closely monitoring other things, such as how long people live, if the cancer comes back or gets worse, how patients feel day-to-day (their quality of life), and any side effects the treatment might cause. This helps them understand the full impact of the treatment on patients.

Key takeaways

The study is for men with high-risk prostate cancer that hasn't spread.
It tests if adding enzalutamide to standard treatment is more effective.
The main goal is to prevent the cancer from spreading to other parts of the body.
It also looks at overall survival, quality of life, and side effects.
Participation involves regular hospital visits and monitoring.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to be a man who is at least 18 years old. The study is specifically for men diagnosed with prostate cancer that is still contained within the prostate area (localised), meaning it hasn't spread to other parts of the body.

However, it's not just any localised prostate cancer. Your doctors must have assessed your cancer as being 'high-risk.' This means that based on certain tests and factors, there's a higher chance your cancer might come back or spread if not treated aggressively.

Only your specialist doctor will be able to tell if your specific prostate cancer meets the detailed criteria for this trial. If you're interested, you should discuss it with them to see if it's a suitable option 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.

Are you male?
Are you 18 years old or older?
Has your doctor told you that your prostate cancer is 'localised' (meaning it hasn't spread)?
Has your doctor said your localised prostate cancer is 'high-risk'?
Are you currently receiving or about to receive hormone therapy and radiation for your prostate cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given one of the study treatments which includes standard hormone therapy and radiation, with or without the drug enzalutamide. The exact medication names for the hormone therapy might include drugs like Casodex, Anandron, or Flutamide. The enzalutamide is given as 40mg capsules.

You will have regular visits to the hospital for appointments. During these visits, doctors will perform examinations, take blood and other samples, and ask you specific questions about how you are feeling and any side effects you might be experiencing. These checks are important to monitor your health and the effectiveness of the treatment.

The total duration of your participation in the study, including the treatment period and follow-up appointments, will depend on the study's protocol and your individual response to treatment. This will be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in this trial might offer potential benefits, such as receiving a new combination treatment for your prostate cancer, which could be more effective at preventing the cancer from spreading. However, there are also potential risks involved, including possible side effects from the medications. Some specific side effects of the drugs used include problems with vision, tiredness, and memory issues, but a full list of potential side effects will be discussed with you. It's important to remember that you can stop participating in the trial at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

—
Unverified
Austria
—
Unverified
Ireland
—
Unverified
Spain

Common questions

What is 'high-risk localised prostate cancer'?

This means your prostate cancer hasn't spread outside the prostate, but doctors believe it has a higher chance of returning or spreading in the future based on certain test results.

What is enzalutamide?

Enzalutamide (also known as Xtandi) is a medication that works by blocking male hormones, which prostate cancer needs to grow. It's often used in hormone therapy.

Will I definitely get the new drug?

This is a 'randomised' study, meaning you will be put into a group by chance. One group gets the standard treatment, and another gets the standard treatment plus enzalutamide.

What kind of tests will I have during the study?

You'll have regular check-ups, blood tests, and possibly scans to see how you are responding to the treatment and to monitor your general health.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason. Your decision will not affect your ongoing medical care.