Active not recruitingPHASE3INTERVENTIONAL

Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer

This research trial is for men with prostate cancer that is still contained within the prostate area but is considered high-risk, meaning it has a higher chance of returning after treatment. We want to find out if adding a drug called enzalutamide to the usual hormone therapy and radiation treatment makes the overall treatment more effective. Enzalutamide is a type of hormone treatment that works differently from the standard hormone therapy. By combining these treatments, the study hopes to reduce the chance of the cancer coming back for men who are already having radiation therapy for their prostate cancer. This is a Phase 3 study, which means it's comparing a new approach to what's currently considered the best standard care.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

University of Sydney

Enrolment target

802

Start

01 Mar 2014

Estimated completion

01 Jun 2026

Prostatic Neoplasms

What is this study about?

This study is looking into new ways to treat prostate cancer that is located in the prostate gland itself but is considered to have a high chance of coming back. When doctors say 'high-risk localised prostate cancer,' it means things like the cancer looking more aggressive under the microscope, or if certain blood tests (like PSA) are very high, or if the cancer has spread to nearby lymph nodes but not to other parts of the body.

Currently, men with this type of prostate cancer often receive hormone therapy combined with radiation treatment. Hormone therapy aims to reduce the amount of male hormones (like testosterone) in the body, as these hormones can fuel prostate cancer growth. Radiation therapy uses high-energy rays to kill cancer cells. This study is testing if adding another medicine called enzalutamide to this standard treatment can make it even better at keeping the cancer from returning.

Enzalutamide is also a type of hormone treatment, but it works in a slightly different way to block the effects of male hormones on cancer cells. By combining it with the usual hormone therapy and radiation, researchers hope to give men with high-risk prostate cancer an even stronger defence against the cancer coming back. This could potentially improve their long-term health and outlook.

Key takeaways

This study is for men with high-risk prostate cancer that hasn't spread.
It tests if adding enzalutamide to standard hormone and radiation therapy helps.
Enzalutamide is a pill that helps block male hormones affecting cancer.
Participation involves random assignment to treatment groups and regular check-ups.
You get detailed information on risks and benefits before deciding to join.

Who may be eligible?

To join this study, you need to be a man with prostate cancer that is considered high-risk but is still contained within the prostate area. This means the cancer hasn't spread to distant parts of your body. Your doctors would have already decided that radiation treatment is a good option for you.

There are also some general health requirements. For example, your blood, liver, and kidney functions need to be working well. You also need to be fit enough for daily activities and able to take part in all the study appointments and tests. You must be at least 18 years old.

However, you wouldn't be able to join if your cancer has certain rare cell types, or if it has spread beyond the immediate area (for example, to distant lymph nodes). Also, if you have any medical reasons that would prevent you from having radiation therapy, or if you've had a history of seizures, this study might not be right 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.

I am a man diagnosed with prostate cancer.
My doctors have told me my prostate cancer is 'high-risk' but hasn't spread to distant parts of my body.
I am suitable for radiation treatment for my prostate cancer.
I am at least 18 years old and generally feel well.
I do not have a history of seizures or other serious health problems that would prevent me from taking part.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of several treatment groups. This decision is made randomly, like flipping a coin. All groups will receive standard hormone therapy, which involves injections, and radiation therapy. Some groups will also receive the study drug, enzalutamide, which is taken as pills. You will have regular visits to the clinic for check-ups, blood tests, and to make sure you are feeling well and handling the treatments properly. You'll also be asked to complete some questionnaires about your quality of life. The exact duration of your treatment and follow-up will be discussed with you, but it typically involves taking medication and attending appointments for a period, followed by ongoing monitoring to see how you're doing over time.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new treatment that might improve your chances of keeping the cancer from returning. However, there are also potential risks involved, including side effects from the study drug, enzalutamide, and from the standard treatments. These side effects will be carefully explained to you by the study doctor. There is no guarantee that the study treatment will benefit you personally. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (69)

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

Dana Farber Cancer Institute
Verified postcode
Boston, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States
Blacktown Hospital
Verified postcode
Blacktown, Australia
Campbelltown Hospital
Verified postcode
Campbelltown, Australia
Chris O'Brien Lifehouse
Verified postcode
Camperdown, Australia
Genesis Cancer Care Newcastle
Verified postcode
Gateshead, Australia
Gosford Hospital
Verified postcode
Gosford, Australia
St George Hospital
Verified postcode
Kogarah, Australia
Liverpool Hospital
Verified postcode
Liverpool, Australia
Orange Health Service
Verified postcode
Orange, Australia
Prince of Wales Hospital
Verified postcode
Randwick, Australia
Royal North Shore Hospital
Verified postcode
St Leonards, Australia

Common questions

What is 'high-risk localised prostate cancer'?

This means your prostate cancer is still only in the prostate area, but it has features that suggest it has a higher-than-average chance of growing back after standard treatment.

What is enzalutamide?

Enzalutamide is a medicine that helps block the effects of male hormones on prostate cancer cells. It's a type of hormone treatment, but it works in a different way to standard hormone injections.

Will I definitely receive enzalutamide if I join?

This is a randomised study, meaning you will be put into a treatment group by chance. Some groups will receive enzalutamide, while others will receive standard care only. Your doctor will explain this in more detail.

What is radiation therapy?

Radiation therapy uses high-energy rays, similar to X-rays, to damage and kill cancer cells. This study uses external beam radiation, which is given by a machine outside your body.

How long will I be in the study?

The study involves a period of treatment, which could be several months, followed by regular check-ups to monitor your health and the cancer over several years. The exact duration will be discussed with you.