Active not recruitingPHASE3INTERVENTIONAL

Phase III Radium 223 mCRPC-PEACE III

This study is for men with prostate cancer that has spread to their bones and is no longer responding to standard hormone therapy. Researchers want to find out if using two medicines, Ra223 and enzalutamide, at the same time is more effective than using enzalutamide by itself. The main aim is to see if the combined treatment can prevent the cancer from growing or spreading further in the bones for a longer period. This is considered a 'Phase III' study, meaning these treatments have been tested before, and now doctors are comparing them directly to see which approach is better for patients. While the study focuses on bones, patients with cancer that has spread to other organs are not included.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Enrolment target

446

Start

01 Oct 2015

Estimated completion

01 Dec 2028

Prostate Cancer

What is this study about?

Imagine you have prostate cancer that's become a bit stubborn and started to spread, specifically to your bones. This is called 'castration-resistant prostate cancer' that has 'metastasized to bone.' Doctors are always looking for better ways to treat this, and sometimes combining treatments can be more powerful than using just one.

This study is investigating two main treatments: enzalutamide, a commonly used medicine for this type of prostate cancer, and Ra223, another medicine that specifically targets cancer in the bones. The idea is to see if using these two together, right from the start, can keep the cancer under control for longer. Think of it like tackling a problem with two different tools instead of just one, hoping for a better and longer-lasting solution.

The main goal is to measure how long it takes for the cancer to start growing or spreading again in the bones, as seen on scans. This is called 'radiological progression-free survival.' By comparing the two groups of patients – one getting both medicines and one getting enzalutamide alone – doctors hope to learn which approach offers the best chance of slowing down the cancer for men like you.

Key takeaways

Researchers are testing if two prostate cancer drugs, Ra223 and enzalutamide, work better together.
This study is for men whose prostate cancer has spread to their bones and is resisting standard hormone therapy.
The main goal is to see if the combined treatment can stop the cancer growing for longer.
You would need to have specific types of bone spread and no cancer in internal organs.
Participation involves regular check-ups, blood tests, and scans.
You can stop participating at any time.

Who may be eligible?

This study is looking for men who have been diagnosed with prostate cancer that has spread to their bones. Your cancer should not be causing you severe pain; mild pain is acceptable. You must have at least four areas in your bones where the cancer has spread, but you shouldn't have cancer that has spread to your internal organs like your lungs or liver.

Your prostate cancer must also be showing signs of getting worse, even though you’re already on hormone therapy. This might mean your PSA blood test results are going up steadily, or new cancer spots are appearing in your bones or lymph nodes. However, if your bone scans show a very widespread and dense spread of cancer (sometimes called a 'superscan'), you wouldn't be able to join.

If you're considering this study, you'll also likely need to be taking medication to protect your bones, or be willing to start it. This is normal practice for men with prostate cancer that has spread to the bones, and it helps to strengthen them. There are specific timings around when you start this bone-protecting medicine and when you'd receive the study drug, so your doctor would guide you through that.

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.

Have I been diagnosed with prostate adenocarcinoma?
Has my prostate cancer spread to my bones?
Is my bone pain mild, or do I have no pain?
Do I have at least four spots of cancer in my bones, but no cancer in my internal organs?
Is my cancer progressing despite hormone therapy (e.g., rising PSA, new bone spots)?
Am I willing to take bone-strengthening medication, if not already on it?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups: one group would receive both enzalutamide and Ra223, and the other group would receive enzalutamide alone. Enzalutamide is taken as pills, and Ra223 is given as an injection.

You would have regular doctor's visits for check-ups, blood tests, and scans (like bone scans, CT scans, or MRI scans) to monitor your cancer and how you're responding to the treatment. These visits would help the doctors understand if the treatment is working and to monitor for any side effects. The exact duration of your participation would depend on how your cancer responds, but there would be follow-up appointments even after active treatment finishes.

Potential risks and benefits

Taking part in this study might offer you the chance to receive a new combination treatment that could potentially be more effective in controlling your prostate cancer. However, all medical treatments carry potential risks and side effects, and adding an extra medicine could mean you experience more or different side effects than with enzalutamide alone. Your medical team will explain all known side effects and monitor you very closely throughout the study. Remember, your participation is completely voluntary; you can choose to withdraw from the study at any time without affecting your usual medical care.

Locations (64)

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

Hopital Universitaire Brugmann
Verified postcode
Brussels, Belgium
Hopitaux Universitaires Bordet-Erasme - Hopital Universitaire Erasme
Verified postcode
Brussels, Belgium
Cliniques Universitaires Saint-Luc
Verified postcode
Brussels, Belgium
Universitair Ziekenhuis Antwerpen
Verified postcode
Edegem, Belgium
AZ Groeninge Kortrijk
Verified postcode
Kortrijk, Belgium
U.Z. Leuven - Campus Gasthuisberg
Verified postcode
Leuven, Belgium
AZ Turnhout
Verified postcode
Turnhout, Belgium
CHU Dinant Godinne - UCL Namur
Verified postcode
Yvoir, Belgium
Hospital de Amor
Verified postcode
Barretos, Brazil
Hospital Erasto Gaertner
Verified postcode
Curitiba, Brazil
Centro Pesquisas Oncologicas
Verified postcode
Florianópolis, Brazil
Oncocentro
Verified postcode
Fortaleza, Brazil

Common questions

What is 'castration-resistant prostate cancer'?

This means your prostate cancer is no longer responding to standard hormone therapy that lowers your testosterone.

What does 'metastatic to bone' mean?

It means the prostate cancer has spread from the prostate gland to your bones.

Are Ra223 and enzalutamide new drugs?

No, both Ra223 and enzalutamide are approved treatments, but this study is looking at using them together rather than separately.

Will I know which treatment I'm receiving?

You will be assigned to a group by chance, like flipping a coin. You and your doctor will know which treatment you are receiving.

What if my cancer spreads to my internal organs?

If your cancer has already spread to internal organs like your lungs or liver, you wouldn't be able to join this particular study.