BiPASS trial: first U.S. patient dosed in Phase 3 prostate cancer diagnosis study

Telix says the first U.S. patient has been dosed in BiPASS, a Phase 3 trial testing Illuccix and Gozellix Ga‑68 PSMA‑PET imaging combined with MRI for initial prostate cancer diagnosis; the trial will enroll about 250 patients across the U.S. and Australia.

Telix Pharmaceuticals announced that the first patient in the United States has been dosed in BiPASS, a Phase 3 study evaluating Illuccix and Gozellix Ga‑68 PSMA‑PET imaging in the initial diagnosis of prostate cancer. The trial is designed to test the use of PSMA‑PET together with MRI in a pre‑biopsy setting and to seek marketing authorization for this approach. The study is prospective and open‑label and will enroll sites in the U.S. and Australia. The dose reported was administered at Urology Austin under the supervision of Dr. Brian Mazzarella and supplied by RLS Radiopharmacies. Key facts: - The BiPASS trial is a Phase 3, prospective, open‑label study planned to enroll about 250 patients across the United States and Australia. - The study will evaluate Illuccix and Gozellix (kits for preparation of gallium Ga‑68 gozetotide) combined with MRI in the pre‑biopsy diagnostic pathway for men with suspected prostate cancer. - Telix describes BiPASS as the first study designed to seek marketing authorization for Ga‑PSMA‑PET imaging in the pre‑biopsy setting. - The first U.S. dose was given under the supervision of Dr. Brian Mazzarella at Urology Austin, supplied by RLS Radiopharmacies. - Telix notes that more than one million prostate biopsies are performed annually in the U.S., with up to 75% reported as negative and some patients declining biopsy recommendations. - Illuccix and Gozellix have regulatory approvals for certain PSMA‑PET indications but have not received regulatory approval for initial prostate cancer diagnosis in any jurisdiction. Summary: If BiPASS meets its primary objectives, Telix reports the study could support changes in how imaging is used before biopsy, with possible effects on biopsy frequency and patient experience. The trial will continue enrollment and follow participants to assess diagnostic performance and outcomes; specific timing for results or regulatory submissions was not provided.