NEW YORK – Bayer said on Thursday that it will begin testing its androgen receptor inhibitor Nubeqa (darolutamide) plus androgen deprivation therapy in a Phase III clinical trial involving certain patients with hormone-sensitive prostate cancer.
In the Phase III study, dubbed ARASTEP, the firm will enroll patients who have no evidence of metastatic disease according to conventional imaging, but who are positive for the prostate-specific membrane antigen (PSMA) based on PET imaging at baseline. Patients will be eligible for the trial if their prostate-specific antigen (PSA) levels double within a year, indicating they have cancers at high risk of biochemical recurrence.
"Many patients with rising PSA levels following surgery or radiation are at an increased risk of developing metastasis," Tara Frenkl, Bayer's senior VP and head of oncology development, said in a statement. "With ARASTEP, we are optimistic about the potential to help patients at this earlier stage of the disease."
In the trial, Bayer will compare the activity of Nubeqa plus androgen deprivation therapy and androgen deprivation therapy alone in approximately 750 patients. The primary endpoint will be radiological progression-free survival as determined by PSMA PET/CT imaging.
Nubeqa in combination with chemo is already approved in the US for metastatic hormone-sensitive prostate cancer patients as well as for non-metastatic castration-resistant prostate cancer.