NEW YORK – Telix Pharmaceuticals on Sunday said it has partnered with Bayer on the Phase III ARASTEP trial of Bayer's Nubeqa (darolutamide) plus androgen deprivation therapy in certain hormone-sensitive prostate cancer patients.
In the trial, Bayer will enroll patients who do not have metastatic prostate cancer according to conventional imaging, but who have at least one prostate-specific membrane antigen (PSMA)-positive lesion per PET imaging. Melbourne, Australia-based Telix will supply its PSMA-directed gallium-based PET imaging agent Illuccix (TLX591-CDx) to screen patients for eligibility.
In ARASTEP, which Bayer first announced in March, the drugmaker is evaluating Nubeqa plus androgen deprivation therapy versus androgen deprivation therapy alone in up to 750 patients in Europe, Japan, and the US. In addition to the PSMA-PET eligibility criteria, patients must have a high risk of biochemical recurrence based on prostate-specific antigen (PSA) levels that double within a year.
"The use of PSMA-PET/CT in this setting is illustrative of the potential for this imaging modality to move beyond diagnosis to a disease management tool," Telix Chief Medical Officer Colin Hayward said in a statement.