Prostate-specific antigen (PSA) response with darolutamide in metastatic hormone-sensitive prostate cancer and its impact on treatment outcomes in the ARASENS trial: a plain language summary

What is this summary about? This summary describes the results from an additional (or post-hoc) analysis of the ARASENS trial in which researchers studied the impact of prostate-specific antigen (PSA) response on treatment outcomes, including how long patients lived, in metastatic hormone-sensitive prostate cancer (mHSPC). mHSPC is a form of prostate cancer that has spread to other parts of the body but can be treated with hormone therapy. The ARASENS trial included 1,305 patients with mHSPC. In this trial, combining darolutamide with two other medications called androgen deprivation therapy (ADT) and docetaxel increased the chances of survival and lowered the risk of death by 32.5%. The percentage of patients reporting medical problems, also called adverse events, was similar to those who received placebo with ADT and docetaxel. What were the PSA results? More than double the patients who received darolutamide, ADT, and docetaxel achieved a deep PSA response compared with those who received placebo, ADT, and docetaxel. Patients who received darolutamide with ADT and docetaxel had more time before their PSA levels increased (durable PSA response) compared with those who received a placebo with ADT and docetaxel. Compared with patients who did not achieve a deep PSA response in the darolutamide group, patients who had a deep PSA response lived longer, had more time before their cancer stopped responding to hormone treatment such as ADT, and had more time before their PSA levels increased. What do these results mean? These results show an important link between a deep PSA response and improved treatment outcomes. They also highlight the importance of monitoring PSA levels and aiming to achieve a deep PSA response at any time during treatment for mHSPC. These findings suggest that triple therapy of darolutamide plus ADT and docetaxel could be considered for all patients with mHSPC, including those with low-volume disease.