A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
This study is investigating a new medication called JNJ-56021927, to be used with standard treatments like abiraterone acetate and prednisone, for men with prostate cancer that has spread and is no longer responding to hormone therapy. The main goals are to understand how the new drug interacts with the existing ones, assess the combination's safety, and get an early idea of how effective it might be. Ultimately, this research aims to help determine the best way to use these medications together in future studies. Participants will take a combination of these drugs daily, and doctors will closely monitor their health, looking for any side effects and checking if the treatment is helping to control the cancer.
At a glance
What is this study about?
This study is for men who have prostate cancer that has spread to other parts of the body (metastatic) and is still growing despite initial hormone treatments (castration-resistant). In this study, doctors are looking at a new drug, JNJ-56021927, in combination with two commonly used medications: abiraterone acetate and prednisone. The main aims are to understand if and how these drugs affect each other in the body, to check for any side effects when they are taken together, and to get an early sense of whether the combination is helping to control the cancer.
By understanding these interactions and the safety of the combination, the researchers hope to find the best way to give these drugs together in future, larger studies. It's a first step to see if this new combination could offer a helpful treatment option for men with this type of prostate cancer.
This is a 'Phase 1' study, which means it's one of the earliest stages of testing a new drug combination in people. The focus at this stage is primarily on safety and finding the right dose, rather than on proving it's better than existing treatments. However, they will also look for early signs of effectiveness.
Key takeaways
- Tests a new drug combo for advanced prostate cancer.
- Aims to understand drug interactions and safety first.
- Participants take study drugs daily for up to 18 months.
- Close monitoring for side effects and cancer changes.
- Open-label study, so you'll know your treatments.
Who may be eligible?
To be considered for this study, you would need to be a man diagnosed with prostate cancer that has spread to other parts of your body. Your cancer would also need to have progressed despite previous hormone treatment, and your testosterone levels should show that you are medically or surgically castrated. You should generally be fit and well enough to take part, with good overall health and organ function.
There are also some reasons why you might not be able to join. For example, if your cancer has spread to your brain, or if your prostate cancer is a rare type called 'small cell carcinoma.' You also couldn't have recently received certain types of other cancer treatments or other experimental drugs. This study also can't include people taking certain medications that could interfere with the study drugs, including some herbal supplements, so your doctor would review all your current medications.
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 with prostate cancer that has spread?
- Has your prostate cancer progressed despite hormone therapy?
- Do you generally feel well enough for a study like this?
- Are you able to stop taking certain interfering medications or herbal supplements?
What does participation involve?
If you join this study, it will start with a check-up period of about 28 days to make sure you're suitable. Once you're in the study, everyone will know which medicines they are receiving. For the first 7 days, you'll take abiraterone acetate and prednisone daily. After that, you'll start taking the new drug, JNJ-56021927, along with abiraterone acetate and prednisone, every day. This daily treatment is expected to continue for up to about 18 months, or for as long as the treatment is helping and not causing too many side effects.
Throughout the study, you'll have regular visits for blood tests to check how the drugs are working in your body, your general safety, and to see if your cancer marker (PSA) is changing. Your doctors and nurses will also keep a close eye on any side effects you might experience. There might also be scans to check your cancer, depending on your doctor's decision. After you stop taking the study drugs, there will be a follow-up period of 30 days to check for any last side effects.
Potential risks and benefits
Locations (7)
- —Verified postcodeLos Angeles, United States
- —Verified postcodeSan Francisco, United States
- —Verified postcodeHouston, United States
- —Verified postcodeVancouver, Canada
- —Verified postcodeMontreal, Canada
- —Verified postcodeRotterdam, Netherlands
- —Verified postcodeSutton, United Kingdom
Common questions
What kind of cancer is this study for?
This study is for men with prostate cancer that has spread (metastatic) and is no longer responding to regular hormone treatments.
What are the main medicines being tested?
The study is looking at a new drug called JNJ-56021927, used alongside existing treatments called abiraterone acetate and prednisone.
How long will I be on the treatment?
Treatment is expected to last for up to about 18 months, or as long as it's helping and not causing too many problems.
Will I know which drugs I'm taking?
Yes, this study is 'open-label,' meaning you and your doctors will know all the medications you are receiving.
Can I stop taking part if I want to?
Yes, you can leave the study at any time, for any reason, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.