This study wants to find out if adding a chemotherapy drug to the usual hormone treatment for metastatic prostate cancer can help slow down or stop the cancer from growing or spreading. We also want to see if this new treatment works better or worse than the standard treatment doctor's use.
If you choose to take part in this study, you will be randomly placed in one of two groups. One group will get the chemotherapy drug called Docetaxel along with the usual hormone treatments for prostate cancer. These hormone treatments include Androgen Deprivation Therapy (ADT) and a medicine called an Androgen-Receptor Pathway Inhibitor (ARPI). If you are in this group, you will get Docetaxel every 21 days for 6 cycles, along with your hormone therapy. The other group will get only the usual hormone treatment. Both groups will keep getting their treatments until the cancer stops responding or the side effects become too severe. After your treatment ends, you will have check-ins for the study every 12 weeks to see how you are feeling and to look for any side effects. These check-ins can be done in-person or over the phone. The study doctor will keep track of your health for the rest of your life. You or your insurance will need to pay for the medical care you get as part of the study.
You might be able to join this study if you are an adult male who is 18 years old or older and has adenocarcinoma of the prostate. To take part, your cancer must have spread, your PSA levels must be elevated above 0.2 and you must have been treated with an ARPI for at least 4 months and ADT for at least 6 months. Your doctor or a study team member will go over these requirements with you. To learn more about who can join this study, please visit ClinicalTrials.gov.
Protocol Number: 25-0680
More information available at ClinicalTrials.gov: NCT06592924
Principal Investigator