A032302 Docetaxel Addition in mCRPC (ASPIRE) - Clinical Trial
What is the Purpose of this Study?
This study has two groups, and you will have an equal chance of being in either one. In Group 1, people get the usual treatment for advanced prostate cancer. This includes hormonal therapy, which can be given as a shot or as pills, and apalutamide, which is taken as four pills once a day. In Group 2, people get a chemotherapy drug called docetaxel along with the usual hormonal therapy and apalutamide. Docetaxel is given through a vein every three weeks for up to six doses. People in this group also get steroids through an IV on the day they receive docetaxel to help reduce side effects.
People who have advanced Prostate Cancer.
Who Can Participate in the Study?
People can join this study if they are older than 18 and have prostate cancer that has been confirmed by lab tests. The cancer must have spread to other parts of the body, such as the bones, certain lymph nodes outside the pelvis, or organs and soft tissues. The spread must be seen on scans like CT, MRI, or a special bone scan. Spread seen only on a PSMA PET scan does not count for this study. People may have already started hormone therapy within the past 120 days, but they cannot have had chemotherapy for prostate cancer.
What is Involved?
This study wants to find out if adding six doses of a chemotherapy drug called docetaxel to the usual treatment for advanced prostate cancer helps people live longer. The usual treatment includes hormonal therapy and apalutamide. Adding docetaxel might help, but it could also cause side effects. Another goal of the study is to see if a genetic test can help doctors learn which patients would benefit the most from adding docetaxel.
Study Details
