Telix Pharmaceuticals Limited has announced a significant milestone in prostate cancer diagnostics. On January 16, 2026, the first patient was dosed in the United States as part of the BiPASS (Biopsy of the Prostate Avoidance Stratification Study) Phase 3 trial. This study aims to evaluate the effectiveness of Telix’s PSMA-PET imaging agents, specifically Illuccix and Gozellix, in enhancing the initial diagnosis of prostate cancer.
The dosing took place at Urology Austin, under the supervision of Dr. Brian Mazzarella, and the agents were supplied by RLS Radiopharmacies. BiPASS is pioneering in its goal to obtain marketing authorization for 68 Ga-PSMA-PET imaging in the pre-biopsy setting. This open-label trial will enroll 250 participants across the U.S. and Australia, aiming to assess whether the combination of MRI with Illuccix and Gozellix can improve diagnostic accuracy and reduce unnecessary biopsies.
Currently, many men with elevated prostate-specific antigen (PSA) levels often face inconclusive MRI results that lead to invasive prostate biopsies. These procedures can be uncomfortable and pose risks, with studies indicating that up to 75% of biopsies yield negative results. In the U.S. alone, over one million prostate biopsies are performed each year, yet a significant number of patients opt out of these recommendations due to the associated stress and complications.
The BiPASS trial seeks to demonstrate that integrating non-invasive imaging via Illuccix and Gozellix early in the diagnostic process can enhance lesion detection. This could lead to either a reduction in the number of unnecessary biopsies or more precise targeting when a biopsy is necessary. Should the trial meet its primary objectives, it could substantially improve patient experiences and significantly broaden access to advanced imaging techniques for men with suspected prostate cancer.
Dr. Mazzarella, who also serves as Vice President of Research for Urology America, expressed enthusiasm for the trial’s potential impact. He stated, “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, emphasized the ongoing transformation in prostate cancer management brought about by Illuccix and Gozellix. He remarked, “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.”
The BiPASS trial builds on encouraging findings from previous studies, including PRIMARY and PRIMARY2, which indicated that MRI combined with 68 Ga-PSMA-11 PET could better define or rule out prostate cancer. Professor Louise Emmett, Principal Investigator for the PRIMARY study, is also involved in the BiPASS Steering Committee.
Illuccix is indicated for PET scanning of PSMA positive lesions in patients with prostate cancer who are candidates for initial definitive therapy. Similarly, Gozellix serves the same purpose, aiding in the identification of metastasis and recurrence based on elevated PSA levels.
Telix Pharmaceuticals, headquartered in Melbourne, Australia, is focused on developing and commercializing therapeutic and diagnostic radiopharmaceuticals. With operations spanning the U.S., United Kingdom, Brazil, Canada, Europe, and Japan, Telix aims to address significant unmet medical needs in oncology and rare diseases. The company is listed on both the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
For more information about Telix Pharmaceuticals, including its latest developments and investor insights, visit their official website at www.telixpharma.com.
