|Age:||19 years or older|
|Keywords:||Castration-Resistant Prostate Cancer, CRPC, prostate cancer|
|Type:||Drug study, Phase [ 1 , 2]|
If you decide to participate in this study and you meet all of the requirements to join the study, you will be asked to do the following:
Take indomethacin by mouth followed by a big glass of water. The dose of indomethacin is 50 to 100 mg once a day. Indomethacin should be taken with food. Always follow the instructions for use of indomethacin given to you by your study doctor. You should take indomethacin around the same time each day. You will also take four enzalutamide pills once a day by mouth (160 mg per day). It can be taken with or without food. This medication is not a study medication; it has been approved by the FDA. You will likely need to take this medication whether you participate in this study or not. Do not miss any tablets/capsules.
You will also be asked to complete a document called a pill diary. At the beginning of each cycle you will be given a pill diary. You will use the pill diary to track when you take your enzalutamide and indomethacin. At the end of each cycle you will be asked to return the completed and signed pill diary, your pill bottles and any remaining enzalutamide and indomethacin to your study doctor. If your study doctor feels it is necessary or if you experience severe side effects, enzalutamide and/or indomethacin may be stopped and then started again at a lower dose or may be stopped completely depending on the results of your laboratory tests. You may continue to be treated with indomethacin until your disease gets worse, you decide not to take part in the study any longer, or your doctor decides it is in your best interest to stop treatment.
Clinic visits will occur every 2 weeks during the first 8 weeks while on-study, and every 4 weeks from then on. At each visit, tell the study staff about any medications you are taking during the study. This includes prescriptions drugs, over-the- counter medicines and vitamins. This is very important. Please tell your study doctor or study staff if you have any unusual symptoms. You will be asked questions about your medical history and about any medications you are currently taking or have taken in the past. You will have a complete physical exam and your vital signs will be taken. You will be asked about your ability to perform every day activities. Up to 10 mL of blood will be taken (less than 1 tablespoon) for routine tests and will be collected every month. Repeat radiologic scans (an X-Ray and/or a CT and/or an MRI) will be taken every other month for the first four months, then every three months.
The study team will discuss the tests and procedures required in greater detail.
Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.