Dr Alumkal on the Effects of the ARESENS Trial on the Treatment of mHSPC

Joshi Alumkal, MD, Wicha Family professor of oncology, professor, Department of Internal Medicine, section head, Prostate and Genitourinary Medical Oncology, associate division chief for Basic Research, Division of Hematology-Oncology, member, the University of Michigan Rogel Cancer Center, director, Epigenetic Therapy, Michigan Center for Translational Pathology, discusses the effects of the phase 3 ARESENS trial (NCT02799602) on the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

For the past several years, oncologists have been treating patients with mHSPC with androgen receptor signaling inhibitors in addition to androgen deprivation therapy (ADT), Alumkal begins. An alternative treatment approach for these patients is ADT plus docetaxel, he notes. However, in the past, oncologists did not know the importance of the androgen receptor signaling inhibitor darolutamide (Nubeqa), or the value of adding an androgen receptor signaling inhibitor to chemotherapy, Alumkal explains.

In light of these new discoveries in the prostate cancer treatment arena, investigators launched the phase 3 ARESENS trial, he expands. This was a randomized phase 3 clinical trial comparing ADT plus docetaxel and placebo vs ADT plus docetaxel and darolutamide in patients with mHSPC. Notably, this double-blind, placebo-controlled, multicenter trial showed an improvement in survival for patients treated with triplet combination therapy consisting of ADT, docetaxel, and darolutamide vs those who received placebo plus ADT and docetaxel, Alumkal says.

These data strongly indicate that if an oncologist chooses to treat a patient with mHSPC with ADT and docetaxel, it's advantageous to add darolutamide to that combination vs omitting the drug, he continues. Based upon these encouraging results, the FDA has approved the use of darolutamide in combination with docetaxel in adult patients with mHSPC, Alumkal emphasizes. Darolutamide plus docetaxel and ADT is an active regimen that oncologists should consider in patients who present with metastatic disease, he concludes.