Telix Pharmaceuticals has partnered with Bayer to supply Illuccix (TLX591-CDx, kit for the preparation of gallium Ga 68 gozetotide injection) for the Phase III ARASTEP study for prostate cancer.
The study will examine the efficacy of Bayer’s androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy versus ADT alone in hormone-sensitive prostate cancer patients.
Patients with high-risk biochemical recurrence who have no metastatic disease evidence by conventional imaging and a positive PSMA-PET/CT at baseline are being enrolled in the study.
For the study, 750 patients across various sites in Japan, Europe and the US will be involved.
Prostate cancer lesions which are not detected by the conventional scans are identified using the more sensitive PSMA imaging.
Telix chief medical officer Dr Colin Hayward said: “We are pleased to supply Bayer and a number of clinical sites in this important study, reflective of Telix’s unique commitment to delivering advanced prostate cancer imaging globally.
“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.”
Approved under the brand name Nubeqa in more than 80 countries globally, darolutamide is an oral ARi that inhibits the growth of prostate cancer cells.