Telix Pharmaceuticals Limited has announced a significant milestone in prostate cancer diagnosis with the dosing of the first patient in the United States for its Phase 3 clinical trial, BiPASSTM. The trial, which aims to evaluate the effectiveness of Telix’s PSMA-PET imaging agents, Illuccix® and Gozellix®, is designed to improve the initial diagnosis of prostate cancer while potentially reducing the need for invasive biopsies. The dose was administered on January 16, 2026, at Urology Austin, under the supervision of Dr. Brian Mazzarella, with the radiopharmaceutical supplied by RLS Radiopharmacies.
BiPASSTM, the first study of its kind, seeks marketing authorization for 68 Ga-PSMA-PET imaging in the pre-biopsy setting. This prospective, open-label trial plans to enroll 250 patients at multiple sites across the United States and Australia. By integrating MRI with Illuccix and Gozellix 68 Ga-PSMA-11 PET imaging, the study intends to enhance diagnostic accuracy and minimize unnecessary biopsies, which are often stressful and carry complications. Currently, over one million prostate biopsies are performed annually in the U.S., with up to 75% yielding negative results. Many patients, in fact, opt against undergoing the biopsy procedure due to its invasive nature.
The objective of BiPASSTM is to demonstrate improved lesion detection and patient stratification through non-invasive imaging early in the diagnostic process. This could enable a decrease in unnecessary biopsies while increasing the precision of those that are performed. If successful, the trial may significantly enhance patient experiences and broaden access to precision imaging for those suspected of having prostate cancer.
Dr. Mazzarella, Vice President of Research for Urology America, expressed enthusiasm about the trial, stating, “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 that the ongoing development of Illuccix and Gozellix is already transforming prostate cancer management. “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,” he remarked.
BiPASSTM builds on promising findings from earlier studies, including PRIMARY and PRIMARY2, which indicated that combining MRI with 68 Ga-PSMA-11 PET could more effectively define or rule out prostate cancer and guide active surveillance before invasive procedures become necessary. Professor Louise Emmett, Principal Investigator for PRIMARY, is also part of the BiPASSTM Steering Committee.
Illuccix and Gozellix, after radiolabeling with 68 Ga, are indicated for PET scanning of PSMA positive lesions in men with prostate cancer who are candidates for definitive therapy or have suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels. While both imaging agents have received regulatory approval in various markets, they have not yet been authorized for the initial diagnosis of prostate cancer in any jurisdiction.
Headquartered in Melbourne, Australia, Telix Pharmaceuticals focuses on developing and commercializing therapeutic and diagnostic radiopharmaceuticals aimed at addressing significant unmet medical needs in oncology and rare diseases. The company operates internationally, including in the United States, United Kingdom, Brazil, Canada, Europe, and Japan, and is listed on both the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).
For more information about Telix Pharmaceuticals and its ongoing initiatives, visit their official website.
