Active not recruitingPHASE3INTERVENTIONAL

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

This study investigates a new medication called apalutamide (ARN-509) for men with prostate cancer. This is for prostate cancer that has not yet spread to other parts of the body but has stopped responding to hormone therapy. Researchers want to find out if apalutamide is effective in stopping the cancer from spreading further and if it is safe to use. You would take study medication daily, either apalutamide or a dummy pill (placebo), alongside your current treatment. The study is a 'Phase 3' trial, meaning it's a key step to understand the drug's full benefits and risks before it might become widely available.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Aragon Pharmaceuticals, Inc.

Enrolment target

1,207

Start

14 Oct 2013

Estimated completion

31 Dec 2027

Prostatic Neoplasms

Results

Results from this study

Posted June 2018

Results have been published for this study.

Primary outcome

Metastasis-Free Survival (MFS) by Blinded Independent Central Review (BICR)

MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography \[CT\] or magnetic resonance imaging \[MRI\] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.

Full results on the registry

What is this study about?

This important study is looking into a new medication called apalutamide. It's for men who have prostate cancer that hasn't spread to other parts of their body yet, but has stopped responding to their usual hormone treatment. Prostate cancer in this situation is known as 'non-metastatic castration-resistant prostate cancer'. The main goal is to see if apalutamide can help delay the cancer from spreading, which is a significant step in managing the disease.

To understand how well apalutamide works and if it's safe, the study compares it to a 'placebo'. A placebo is a pill that looks exactly like the study drug but doesn't contain any active medicine – it's often called a 'dummy pill'. This comparison helps doctors know if any improvements are genuinely due to the new drug, rather than other factors.

This is a 'Phase 3' clinical trial, which means it's one of the final steps in testing a new medicine. Previous research has already shown some promising signs that apalutamide might be helpful. This large trial will gather more detailed information about both its effectiveness and any potential side effects, helping to build a complete picture of its benefits and risks.

Key takeaways

This study evaluates a new drug, apalutamide, for prostate cancer that hasn't spread but is no longer responding to standard hormone therapy.
The main aim is to see if apalutamide can stop or delay the cancer from spreading.
You would take the study drug or a placebo daily, alongside your usual care.
This is a 'Phase 3' trial, a crucial step to understand the drug's full effects.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be an adult man with prostate cancer that has been confirmed by a doctor. Your prostate cancer must not have spread to other parts of your body. It also needs to be 'castration-resistant', meaning your current hormone therapy is no longer fully controlling your prostate specific antigen (PSA) levels.

There are also specific checks for your PSA levels and how they've changed over time. You would need to be maintaining low testosterone levels with your current treatment. If you've had certain other treatments recently, such as other hormone therapies, major surgery, or radiation, there might be a waiting period before you can join.

This study is not for you if your cancer has already spread to distant parts of your body, including your brain or spine. Also, if you have significant symptoms from your prostate cancer that need urgent treatment, this study might not 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 with prostate cancer?
Has your doctor confirmed your prostate cancer has not spread to other parts of your body?
Is your prostate cancer no longer fully responding to your current hormone therapy (it's 'castration-resistant')?
Are your testosterone levels currently low due to your treatment?
Do you have a good general level of health and activity?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance (like flipping a coin) to one of two groups. Two out of every three participants will receive the new medication, apalutamide, while one out of three will receive a placebo. You and your study doctor won't know which group you are in, but the doctor can find out in an emergency. Everyone in the study will continue to receive their standard prostate cancer treatment alongside the study medication or placebo.

You will take the study medication as a pill every day. Each cycle of treatment lasts 4 weeks (28 days). The number of cycles you complete will depend on how your body responds to the treatment and whether you experience any side effects. You will continue treatment until your cancer shows signs of getting worse, or if side effects become too bothersome, or if you decide you no longer wish to take part.

Potential risks and benefits

Taking part in a study like this could potentially offer a benefit by giving you access to a new treatment, apalutamide, before it's widely available. This treatment might help delay your prostate cancer from spreading. However, there's also a chance you could receive the placebo. As with all medications, there's a risk of side effects, though these will be closely monitored by the study team. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (379)

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

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Birmingham, United States
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Anchorage, United States
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Chandler, United States
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Tucson, United States
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Duarte, United States
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Fullerton, United States
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Laguna Woods, United States
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Los Angeles, United States
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Orange, United States
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Roseville, United States
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Sacramento, United States
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San Bernardino, United States

Common questions

What is 'castration-resistant' prostate cancer?

It means the prostate cancer is no longer fully controlled by treatments that lower testosterone levels, even though your testosterone levels are still low.

What is a placebo?

It's a 'dummy pill' that looks like the study drug but doesn't contain any active medicine. It helps researchers compare the new drug's effects.

Will I know if I'm getting the drug or the placebo?

No, neither you nor your doctor will usually know, but your doctor can find out if there's a medical emergency.

How long will I be in the study?

You'll continue treatment for as long as it's helping, you're not experiencing significant side effects, and your cancer isn't worsening.

Can I leave the study if I want to?

Yes, you can choose to leave the study at any time, and this will not affect your future medical care.