The phase three clinical trial reached a milestone with its first American participant receiving treatment, advancing research into improved diagnostic approaches for prostate cancer detection.
MELBOURNE, Australia and INDIANAPOLIS, Jan. 16, 2026 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the first patient in the United States (U.S.) has been dosed in BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study), a Phase 3 trial to evaluate the use of Telix’s commercial PSMA-PET[1] imaging agents, Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) and Gozellix® (kit for the preparation of gallium Ga 68 gozetotide injection) in the initial prostate cancer diagnosis setting. The dose was administered under the supervision of Dr. Brian Mazzarella at Urology Austin and supplied by RLS Radiopharmacies.
BiPASS™ is the first study designed to gain marketing authorization for 68Ga-PSMA-PET[2] 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 MRI[3] with Illuccix/Gozellix 68Ga-PSMA-11 PET can improve diagnostic accuracy and reduce unnecessary biopsies compared to current standard practice. Men with elevated PSA[4] often proceed from an inconclusive MRI to template prostate biopsy. This procedure is stressful and unpleasant, can lead to complications[5] and frequently proves to be of no benefit to the patient[6].
In the U.S., more than one million prostate biopsies are performed annually, yet up to 75% are negative[6], and one in four patients declines the physician recommendation of receiving a biopsy[7]. The objective of BiPASS™ is to demonstrate improved lesion detection and patient stratification by integrating non-invasive molecular Illuccix/Gozellix 68Ga-PSMA-11 PET imaging early in the diagnostic pathway, to enable biopsy de-escalation or, alternatively, greater biopsy precision when administered.
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.
Dr. Mazzarella, Vice President of Research for Urology America, said, “We’re excited to participate in the BiPASS trial at Urology Austin, which brings together promising technologies and emerging trends in patient care. 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, 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.”
