Dr. Shore on overall safety profile of darolutamide in prostate cancer patients

Neal D. Shore, MD, FACS, director of the Carolina Urologic Research Center, Atlantic Urology Clinics in Myrtle Beach, South Carolina, discusses the safety profile of darolutamide (Nubeqa) in patients with prostate cancer.

Shore discussed the open-label rollover study from the phase 3 ARAMIS trial of darolutamide at the 2023 Genitourinary Cancers Symposium. Based on findings from the ARAMIS trial, darolutamide (Nubeqa) was approved by the FDA for the treatment of patients with nonmetastatic castration-resistant prostate cancer. Darolutamide also has an approved indication for use in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer.

Video Transcript

With darolutamide, and its drug class of androgen receptor signaling inhibitors, patients can experience increased fatigue. You can get some occasional musculoskeletal discomfort and the occasional urinary tract infection or hot flush. But what we saw in phase 3 studies and what we've seen in earlier studies—early phase 1/2 studies—is really a paucity of cognitive impairment and a paucity of depression with darolutamide that we've seen across the class of androgen receptor signaling inhibitors, particularly cognitive impairment. We haven't seen a high incidence of falls with darolutamide and we haven't seen a particular high incidence of hypertension or cardiovascular effects, and a very less than 1% incidence of a grade 1/2 type rash.

The transcript has been edited for clarity.