Telix BiPASS Phase 3 Trial Announces 1st Patient Dosed in U.S.

Telix Pharmaceuticals Limited announced that the first U.S. patient has been dosed in the BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study), a Phase 3 clinical trial evaluating the use of PSMA-PET imaging earlier in the prostate cancer diagnostic pathway.

The patient was dosed at Urology Austin under the supervision of Dr. Brian Mazzarella, with radiopharmaceutical supply provided by RLS Radiopharmacies. BiPASS is assessing Telix’s commercial PSMA-PET imaging agents, Illuccix® and Gozellix®, both kits for the preparation of gallium Ga 68 gozetotide injection, in men undergoing initial evaluation for suspected prostate cancer.

BiPASS is the first study designed to support marketing authorization for ^68Ga-PSMA-PET imaging in the pre-biopsy setting. The prospective, open-label Phase 3 trial will enroll approximately 250 patients across sites in the U.S. and Australia. Its primary goal is to determine whether combining MRI with Illuccix/Gozellix ^68Ga-PSMA-11 PET improves diagnostic accuracy and reduces unnecessary prostate biopsies compared with current standard practice.

Men with elevated prostate-specific antigen (PSA) levels frequently proceed from inconclusive MRI scans to template prostate biopsy—an invasive procedure that can be stressful, unpleasant, and associated with complications, while often providing no clinical benefit. In the U.S., more than one million prostate biopsies are performed each year, yet up to 75% are negative, and about one in four patients declines a physician-recommended biopsy.

The BiPASS study aims to demonstrate that earlier integration of non-invasive molecular PSMA-PET imaging can improve lesion detection and patient stratification, enabling biopsy de-escalation or, when needed, more precise targeting.

“We’re excited to participate in the BiPASS trial at Urology Austin, which brings together promising technologies and emerging trends in patient care,” said Dr. Brian Mazzarella, Vice President of Research for Urology America. “If BiPASS is successful in meeting its primary endpoint, it could eliminate the need for biopsy—reducing risks, side effects, and costs—and improve decision-making for providers and patients.”

Kevin Richardson, Chief Executive Officer of Telix Precision Medicine, added, “Illuccix and Gozellix are already transforming how clinicians treat and manage prostate cancer. By initiating this trial, we are reinforcing Telix’s commitment to patient centricity, clinical innovation, and industry leadership—with the goal of eliminating invasive biopsy.”