Telix (ASX:TLX) has agreed with Bayer to supply its Illuccix for a Phase 3 study investigating the efficacy of the German company's Nubeqa (darolutamide) plus androgen deprivation therapy in hormone-sensitive prostate cancer.
The study involves patients with high-risk biochemical recurrence with no evidence of metastatic disease by conventional imaging and a positive PSMA (prostate-specific membrane antigen)-PET (positron emission tomography)/CT (computed tomography) at baseline.
Illuccix (TLX591-CDx, kit for the preparation of gallium Ga 68 gozetotide injection) is a radioactive diagnostic agent indicated for PET of PSMA-positive lesions in men with prostate cancer.
The study will enrol up to 750 patients across various sites in Europe, Japan and the US.
Telix said the more sensitive PSMA imaging may identify prostate cancer lesions not detectable by conventional imaging such as CT scans, magnetic resonance imaging and bone scans.
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.”