Adaptive Androgen Deprivation Therapy and Docetaxel for the Treatment of Metastatic Castration Sensitive Prostate Cancer
This phase IIa trial tests how well androgen deprivation therapy (ADT) and docetaxel, given using an on and off (adaptive) schedule, work in treating patients with prostate cancer that is sensitive to the use of drugs to suppress the function of the testicles (castration sensitive) and has spread from where it first started to other places in the body (metastatic). ADT uses drugs, such as degarelix, leuprolide, triptorelin, and relugolix, to block production or interfere with the action of male sex hormones. Abiraterone, enzalutamide, apalutamide, and darolutamide are in a class of medications called androgen receptor inhibitors. They work by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. In this trial, patients are monitored during treatment by the amount of prostate-specific antigen (PSA) found in their blood, as well as imaging scans. Once the cancer achieves an adequate response, patients may be asked to take a treatment break, and treatment restarted after their PSA reaches a threshold determined by the cancer’s prior PSA response. Giving adaptive ADT and docetaxel may work better than the standard schedule in treating patients with metastatic castration-sensitive prostate cancer (mCSPC).