Impact of statin use on outcomes with darolutamide plus docetaxel in metastatic hormone sensitive prostate cancer: a post-hoc analysis of the ARASENS trial

Prostate cancer is one of the most common cancers affecting men worldwide, and many people are impacted either directly or through family members. When prostate cancer spreads beyond the prostate but still responds to hormone-lowering treatment, it is called metastatic hormone-sensitive prostate cancer (mHSPC).

A hormone is a natural chemical messenger made by the body that travels through the bloodstream to control how organs and tissues work. In prostate cancer, the key hormones are androgens, such as testosterone and dihydrotestosterone (DHT), which can help the cancer grow. Many treatments aim to lower these hormones or block their effects, a strategy known as androgen deprivation therapy (ADT).

Standard treatment for mHSPC often includes ADT, chemotherapy with a drug called docetaxel, and sometimes a newer class of medicines called androgen-receptor pathway inhibitors (ARPi), such as darolutamide. These treatments work together to limit the cancer’s ability to use hormones to grow.

Statins are widely used medicines that lower cholesterol, which is a fatty substance in the blood that the body needs in small amounts but that can build up and cause heart disease. Earlier findings have suggested that statins may also slow prostate cancer or help patients live longer. These findings mostly come from studies of men receiving hormone-blocking treatments, but we still do not know whether statins offer the same benefit for people receiving today’s more intensive “triplet therapy,” which combines ADT, docetaxel, and an ARPi.

To explore this, we will study data from the large international ARASENS trial, which included people with metastatic hormone-sensitive prostate cancer. In ARASENS, all patients received hormone therapy plus docetaxel chemotherapy and were then randomly assigned to receive either Darolutamide or a placebo (a pill with no active medicine). While the main purpose of the trial was to see whether darolutamide improved survival, we will focus instead on whether taking statins made a difference in survival outcomes regardless of treatment group.

By carrying out this research, we hope to learn whether an inexpensive, widely available medication like a statin could help improve outcomes for people with advanced prostate cancer.