Bayer registers India observational study of darolutamide in mHSPC

Bayer's registry activity for the week centers on a single new observational trial filing in India.

• Bayer registered an observational post-marketing surveillance study, "PACE mHSPC" (NCT07806591), in patients with metastatic hormone-sensitive prostate cancer. The study is not yet recruiting, with an estimated start date of October 15, 2026 and primary completion estimated for November 15, 2028¹. The trial will track real-world safety of darolutamide combined with androgen deprivation therapy, looking at adverse events, serious adverse events, special-topic adverse events, treatment changes, and shifts in lab values, vital signs, and ECOG performance status¹. The design calls for an estimated enrollment of 60 participants¹ in a single-arm cohort, using darolutamide, also known as NUBEQA or BAY 1841788, dosed at 300 mg film-coated tablets alongside ADT¹.