An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

This study is looking for adult men aged 18 years and older who have been diagnosed with prostate cancer that has spread to other parts of the body, but is still responding to hormone treatment. This means you have metastatic hormone-sensitive prostate cancer (mHSPC). Your prostate cancer must also show a specific type of spread, usually to bones or other organs, as seen on scans.

You would not be able to join if your cancer has already been treated with certain newer hormone therapies like enzalutamide or abiraterone for advanced disease. However, if you received some of these treatments for localized prostate cancer more than a year ago, you might still be eligible. Also, the study is not for men whose cancer has only shown up as a change in blood test results without clear signs of spread on scans, or if you have a specific mixed type of prostate cancer.

If you decide to take part, the study will involve several stages. First, there will be a screening period lasting up to 28 days to check if you meet all the requirements. If you do, you'll start the treatment period. During this time, you'll take JSB462, along with either abiraterone or enzalutamide, every day by mouth. This treatment will continue for as long as it's helping you and you're not experiencing difficult side effects, or until you or your doctor decide to stop.

After you stop taking the study medication, there will be a safety follow-up period of about 30 days to check on your health. Following this, there will be a longer-term follow-up period where the study team may continue to collect information on your health, how you are doing, and if the treatment continues to have an effect. The total length of your participation will depend on how long you receive treatment and the final end date of the study.