Telix Pharmaceuticals Completes Enrollment in BiPASS Study for Prostate Cancer Imaging

Telix Pharmaceuticals Completes Enrollment in BiPASS Study for Prostate Cancer Imaging

Telix Pharmaceuticals Ltd. has successfully completed patient enrollment for its Phase 3 BiPASS study involving the PSMA-PET imaging agents Illuccix® and Gozellix®. This study focuses on enhancing prostate cancer diagnosis in the pre-biopsy setting.

The BiPASS study, an acronym for Biopsy of the Prostate Avoidance Stratification Study, includes a total of 350 patients from the United States and Australia. It seeks to evaluate whether the integration of 68Ga-PSMA-PET imaging with MRI can refine diagnostic accuracy, minimize unnecessary biopsies, and enhance biopsy targeting when contrasted with the standard diagnostic approach.

Telix has established positive communication with the U.S. Food and Drug Administration (FDA) regarding a New Drug Application (NDA) pathway. If sanctioned, this could lead to new product reimbursement, thereby expanding patient access to 68Ga-PSMA-PET imaging technologies. This development is poised to significantly impact the management of prostate cancer by potentially broadening the usage of precision imaging in initial diagnoses.

Prostate cancer remains a significant health burden, with over three million biopsies performed globally each year. Many of these biopsies, up to 75%, return negative results, presenting a clinical challenge as patient compliance remains difficult, with one in four declining recommended biopsies. The BiPASS study builds on previous trials—namely, the PRIMARY and PRIMARY2 studies—which have demonstrated the efficacy of combining 68Ga-PSMA-PET imaging with MRI in improving detection rates for clinically significant prostate cancer and reducing unnecessary biopsies significantly.

Professor Louise Emmett, Director of Theranostics and Nuclear Medicine at St. Vincent’s Hospital and BiPASS investigator, remarked on the milestone: “Completing patient enrollment in BiPASS is crucial for men with suspected prostate cancer, especially those with inconclusive MRI results. The study promises to change standard care practices, streamline diagnostic processes, and aid in earlier treatment interventions.”

Dr. Brian Mazzarella, Vice President of Research for Urology America, highlighted the advancements stating, "PSMA-PET imaging with Illuccix and Gozellix has transformed prostate cancer staging and management. The combination with MRI offers a superior opportunity for detecting clinically significant cases, thus aiding more informed diagnosis."

Moreover, Dr. David N. Cade, Telix's Chief Medical Officer, emphasized the strong clinical interest in more accurate non-invasive diagnostic methods, noting that the swift completion of the recruitment process reflects this enthusiasm. Successful execution and data from BiPASS, combined with findings from previous trials, could redefine the criteria for biopsy necessity, establish a wider clinical application, and enhance healthcare outcomes.

For more information, visit Telix Pharmaceuticals.