All studies
Active not recruitingPHASE3INTERVENTIONAL

Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer

This research study is investigating an advanced prostate cancer treatment. It's for men newly diagnosed with prostate cancer that has spread to other parts of the body, known as metastatic prostate cancer. The study aims to see how effective a drug called enzalutamide is when given as an initial treatment. It compares enzalutamide with a standard treatment (another type of hormone therapy or surgery to remove the testicles) to understand which helps patients more. Researchers hope to find out if starting enzalutamide early can improve outcomes for these men. Your participation could help us learn more about the best ways to treat this type of cancer.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
University of Sydney
Enrolment target
1,125
Start
01 Mar 2014
Estimated completion
30 Jun 2027

What is this study about?

This study is looking at a type of prostate cancer that has spread from the prostate to other parts of the body. This is called 'metastatic prostate cancer'. For these men, the first treatment often involves reducing the amount of male hormones in the body, which helps slow down the cancer. This is called 'androgen deprivation therapy' or ADT.

The study wants to compare a newer drug called enzalutamide with an older, more common hormone treatment, or surgery to remove the testicles. All of these treatments aim to lower male hormones. Researchers want to see if enzalutamide is better at treating newly diagnosed metastatic prostate cancer when it's used as the very first treatment.

The goal is to find clearer answers about which treatment approach works best for men when they are first diagnosed with metastatic prostate cancer. By comparing these treatments, doctors hope to offer the most effective options to future patients.

Key takeaways

  • This study compares enzalutamide with standard hormone treatments for advanced prostate cancer.
  • It's for men newly diagnosed with prostate cancer that has spread (metastatic).
  • The aim is to find out if starting enzalutamide early is more effective.
  • Participation involves regular hospital visits, tests, and taking medication.
  • Your health and organ function need to meet specific requirements to join.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is for men aged 18 or older who have been recently diagnosed with prostate cancer that has spread to other parts of the body. You would need to be starting your first hormone treatment (androgen deprivation therapy) for this advanced stage of cancer.

To be included, your body's organs, like your blood, liver, and kidneys, need to be working well enough. Doctors will also check your general health and how well you can go about your daily activities. You must be willing to follow all the study's instructions, including taking medication and attending appointments.

However, some specific health conditions might mean you can't join. For example, if you have certain rare types of prostate cancer, a history of seizures, a recent stroke, or serious heart problems within the last three months, the study might not be suitable 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.

  1. Are you a man aged 18 or older?
  2. Do you have prostate cancer that has spread?
  3. Are you about to start your first hormone treatment for this advanced cancer?
  4. Are your blood tests, liver, and kidneys working well?
  5. Do you have good general health and few serious medical conditions recently?
Answer every question to see your result.

What does participation involve?

If you join this study, you would first fill out some health questionnaires. Then, you would be randomly assigned to receive either enzalutamide or a standard hormone treatment (either medication or surgery). You would start your assigned treatment within 7 days of being accepted into the study. This involves taking medication, or having surgery as appropriate. You'll have regular hospital visits for check-ups, blood tests, and scans to see how your body is responding to the treatment. These visits will continue for a certain period, and even after you stop the main treatment, there will be follow-up appointments to track your long-term health. The total duration of your participation, including follow-up, could be several years.

Potential risks and benefits

Taking part in this study could offer you access to a new treatment option that might be more effective than current standard care for metastatic prostate cancer. However, like all medications, enzalutamide can have side effects, and your doctor will discuss these with you. There's no guarantee that the treatment will work for everyone, and it might not improve your condition. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (82)

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
  • Chris O'Brien Lifehouse
    Verified postcode
    Camperdown, Australia
  • Coffs Harbour Health Campus
    Verified postcode
    Coffs Harbour, Australia
  • Concord Cancer Centre - Concord Repatriation General Hospital
    Verified postcode
    Concord, Australia
  • St Vincent's Hospital Sydney
    Verified postcode
    Darlinghurst, Australia
  • Nepean Cancer Care Centre
    Verified postcode
    Kingswood, Australia
  • St. George Hospital
    Verified postcode
    Kogarah, Australia
  • Central West Cancer Services
    Verified postcode
    Orange, Australia
  • Port Macquarie Base Hospital
    Verified postcode
    Port Macquarie, Australia
  • Prince of Wales Hospital
    Verified postcode
    Randwick, Australia
  • Genesis Care North Shore
    Verified postcode
    St Leonards, Australia
  • Tamworth Rural Referral Hospital
    Verified postcode
    Tamworth, Australia

Common questions

What is 'metastatic prostate cancer'?

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

What is 'androgen deprivation therapy (ADT)'?

It's a treatment that lowers male hormones in your body, which helps slow down prostate cancer growth.

Is enzalutamide a new drug?

Enzalutamide is a newer type of hormone therapy already approved for prostate cancer, but this study is looking at using it earlier.

What does 'randomly assigned' mean?

It means a computer will decide which treatment you receive, like flipping a coin, to make the study fair.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time without it affecting your medical care.

How to find out more

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

Discussion

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