Dr. Berg on the Role of the PEACE-1 and ARASENS Trials in Expanding mHSPC Treatment

Stephanie Berg, DO, Dana-Farber Cancer Institute, discusses two key clinical trials that have advanced the standard of care in metastatic hormone-sensitive prostate cancer (mHSPC).

Recent changes in the treatment paradigm for mHSPC began with results from the phase 3 PEACE-1 trial (NCT01957436), which evaluated the clinical benefit of triplet therapy in the frontline setting. Researchers administered the hormonal agent abiraterone acetate (Zytiga) in combination with androgen deprivation therapy (ADT) and docetaxel. This trial has been ongoing since 2013, and data were most recently reported at the 2022 ESMO Congress. Results showed that patients who achieved a prostate specific antigen (PSA) level of less than 0.2 at 8 months experienced improved overall survival.

First approved in the nonmetastatic setting for castration-resistant prostate cancer, the phase 3 ARASENS trial (NCT02799602) introduced darolutamide (Nubeqa) as another novel therapeutic option for patients with high-volume disease. Darolutamide typically exhibits less toxicity compared with chemotherapy because it doesn’t cross the blood-brain barrier. As a result, patients experience fewer problems with cognition, fatigue, and general ability. This feature makes darolutamide a unique and favorable option for both patients and physicians.

Although FDA approval of these hormonal agents for patients with high-volume disease has improved the treatment landscape, National Comprehensive Cancer Network guidelines for their use and administration are still evolving. Currently, the FDA requires darolutamide to be administered alongside docetaxel, while abiraterone acetate can be administered with or without chemotherapy.