Telix Pharmaceuticals Launches Prostate Cancer Clinical Trial in the U.S.

Telix Pharmaceuticals announces that the first patient in the U.S. has been dosed in BiPASS, a Phase 3 trial to evaluate the use of Telix's commercial PSMA-PET1 imaging agents, Illuccix and Gozellix in the initial prostate cancer diagnosis setting. BiPASS is the first study designed to gain marketing authorization for 68Ga-PSMA-PET2 imaging in the pre-biopsy setting. The prospective, open-label Phase 3 trial will enroll 250 patients across sites in the U.S. and Australia. The study aims to determine whether combining MRI3 with Illuccix/Gozellix 68Ga-PSMA-11 PET can improve diagnostic accuracy and reduce unnecessary biopsies compared to current standard practice. Men with elevated PSA4 often proceed from an inconclusive MRI to template prostate biopsy. This procedure is stressful and unpleasant, can lead to complications and frequently proves to be of no benefit to the patient, the company said. If the BiPASS study achieves its primary objectives, it could lead to a reduction in unnecessary biopsies, improved patient experience, and a significant expansion of access to precision imaging for patients with suspected prostate cancer, potentially increasing the use of 68Ga-PSMA-11 PET in a large new patient population.