Active not recruitingPHASE3INTERVENTIONAL

An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)

This research study is for men with advanced prostate cancer that has spread to other parts of the body and is no longer responding to initial hormone treatment, but who haven't yet had chemotherapy. Researchers want to find out if adding a drug called apalutamide to the standard treatment of abiraterone acetate and prednisone is more effective than the standard treatment alone. The main goal is to see if this new combination helps men live longer without their cancer growing or spreading further. This is a Phase 3 trial, which means it's testing a promising treatment that has already shown good results in earlier studies, against the best available treatment to confirm its benefits and safety.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Aragon Pharmaceuticals, Inc.

Enrolment target

982

Start

26 Nov 2014

Estimated completion

31 Dec 2027

Prostatic Neoplasms

What is this study about?

This study is investigating a new way to treat prostate cancer that has spread to other parts of the body and has become resistant to standard hormone therapy. This type of cancer is called 'metastatic castration-resistant prostate cancer' (mCRPC). The men joining this study would not have had chemotherapy for their prostate cancer yet.

Currently, many men with this condition are treated with a combination of medicines called abiraterone acetate and prednisone. This study wants to see if adding another medicine, called apalutamide, to this existing treatment can help more. The main thing they're looking for is whether this new combination can stop the cancer from growing or spreading for a longer period of time, as seen on scans.

This is a 'randomised, double-blind, placebo-controlled' study. This means that participants will be assigned to one of two groups by chance – like flipping a coin. One group will receive the apalutamide combination, and the other will get the standard treatment along with a 'dummy' pill (placebo) that looks like apalutamide but contains no active drug. Neither you nor your doctor will know which treatment you are receiving until the end of the study. This helps ensure the results are fair and unbiased. The study is also 'multicenter', meaning it involves many hospitals and experts working together.

Key takeaways

Investigating a new combination of drugs for advanced prostate cancer.
Aims to see if apalutamide improves treatment for men who haven't had chemotherapy.
Compares a new drug combination against the current standard treatment.
Participants are assigned to treatment groups by chance (randomised).
Neither you nor your doctor will know which treatment group you are in (double-blind).
Close monitoring of your health and cancer progress throughout the study.

Who may be eligible?

This study is looking for men diagnosed with prostate cancer that has spread beyond the prostate (metastatic disease). Your cancer must be an adenocarcinoma type, which is the most common form of prostate cancer, and it must have become resistant to initial hormone therapy. We'll check this by looking at your PSA levels and confirming that despite ongoing hormone treatment, your PSA has risen, and your cancer is showing signs of growth on scans.

You should not have had chemotherapy for your prostate cancer before, though some prior hormone treatments are allowed, provided there's a waiting period before joining the study. You also shouldn't have specific types of prostate cancer like small cell or neuroendocrine carcinoma, or known cancer spread to the brain.

There are also some restrictions on other medications you might be taking, especially those that could affect seizure risk, or certain herbal products. If you are taking any of these, your study doctor will discuss whether they need to be stopped or changed before you can join.

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 a man diagnosed with prostate cancer?
Has your prostate cancer spread to other parts of your body?
Is your prostate cancer no longer responding to initial hormone therapy?
Have you NOT had chemotherapy for your prostate cancer yet?
Do you have a common type of prostate cancer called adenocarcinoma?
Are you able to attend regular hospital visits for check-ups and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first go through a 'screening phase' where doctors will do various tests and scans to make sure you meet all the study requirements. If you're eligible, you'll then enter the 'treatment phase'. You'll be randomly assigned to one of two groups: either you'll receive apalutamide combined with abiraterone acetate and prednisone, or you'll receive abiraterone acetate and prednisone along with a placebo (a dummy pill).

Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to monitor your cancer and your general health. Your doctors will keep a close eye on any side effects you might experience. After the main treatment period, there will be a 'follow-up phase' where your health will continue to be monitored. Some participants might be offered the chance to continue with open-label treatment (where everyone knows what medicine they are getting) after the main part of the study. The total duration of your participation will depend on how your cancer responds to treatment.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available, and receiving close medical monitoring. However, there's no guarantee that the treatment will be effective for you, or that it will be better than standard care. Like all medications, the study drugs can have side effects, which may range from mild to serious. The research team will explain all the known risks and potential side effects in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (173)

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

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Phoenix, United States
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La Mesa, United States
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Los Angeles, United States
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Modesto, United States
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San Diego, United States
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San Francisco, United States
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Santa Barbara, United States
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Aurora, United States
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Denver, United States
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Jensen Beach, United States
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Lakeland, United States
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New Port Richey, United States

Common questions

What does 'metastatic castration-resistant prostate cancer' mean?

It means your prostate cancer has spread to other parts of your body and is no longer being controlled by standard hormone treatments.

What is a 'Phase 3' study?

Phase 3 studies compare a new treatment that has shown promise in earlier research against the best available standard treatment to confirm its benefits and safety.

Will I know which treatment I am getting?

No, this is a 'double-blind' study, meaning neither you nor your doctor will know which treatment you are receiving until the study is over.

What is 'radiographic progression-free survival'?

It's the length of time a person lives with their cancer without it getting worse or spreading further, as seen on scans like X-rays or CT scans.

Can I still participate if I’ve had prostate cancer treatment before?

Yes, but it depends on the type of treatment. You can't have had chemotherapy for prostate cancer, but prior hormone therapy is generally fine, with a waiting period.