Telix completes enrollment in Phase 3 BiPASS study for prostate cancer diagnosis
Telix Pharmaceuticals has completed enrollment in its Phase 3 BiPASS study, a pivotal trial evaluating the diagnostic performance of 68Ga-PSMA-PET combined with MRI for the detection of prostate cancer prior to biopsy. The study, which enrolled 350 patients across the United States and Australia, aligns with the U.S. Food and Drug Administration (FDA) on a pathway for a New Drug Application (NDA) that could support new product reimbursement and enhance patient access to 68Ga-PSMA-PET imaging.
BiPASS, the first registrational study of 68Ga-PSMA-PET in the pre-biopsy setting, aims to determine whether the combination of MRI and 68Ga-PSMA-PET can enhance diagnostic accuracy, reduce unnecessary biopsies, or improve targeting of biopsies compared to current standard practices. The trial, which involved a prospective, open-label Phase 3 design, focuses on men with suspected prostate cancer, particularly those with equivocal MRI findings.
Approximately three million prostate biopsies are performed globally each year, with up to 75% of these resulting in negative findings. Patient compliance with biopsy recommendations remains challenging, with about one in four patients declining the procedure. Biopsies can be stressful, painful, and may lead to complications, with no real diagnostic benefit for many patients.
Professor Louise Emmett, Director of Theranostics and Nuclear Medicine at St Vincent’s Hospital and a BiPASS Investigator, stated, "Completing patient enrollment in BiPASS is a significant milestone for men with suspected prostate cancer, especially those with equivocal MRI findings. The PRIMARY and PRIMARY2 studies demonstrated that 68Ga-PSMA-PET, when used alongside MRI, can safely halve the number of biopsies required without missing clinically significant prostate cancer. BiPASS now has the potential to fundamentally change the current standard of care, streamlining the diagnostic pathway, accelerating treatment decision-making, and ensuring that men receive the most appropriate therapy earlier in their treatment journey."
Dr. Brian Mazzarella, Vice President of Research for Urology America and a BiPASS Investigator, added, "PSMA-PET imaging with tracers such as Illuccix and Gozellix has already transformed how we stage and manage prostate cancer. By integrating the functional information from PSMA-PET with the detailed anatomic information provided by MRI, we have an unprecedented opportunity to improve the detection of clinically significant prostate cancer and guide more informed diagnostic decisions. For patients, this approach has the potential to reduce unnecessary procedures, lower procedural risk, ease anxiety, and enable more precise, individualized treatment decision-making."
Dr. David N. Cade, Telix Group Chief Medical Officer, commented, "Recruitment of BiPASS was completed rapidly, reflecting strong enthusiasm from clinicians and patients for a more accurate, non-invasive approach to diagnosis. We believe BiPASS may represent a transformative event in the management of prostate cancer, alongside the compelling data from the PRIMARY studies. If approved, the pathway could define and lead a patient-first approach that significantly broadens access to gallium-based PSMA-PET imaging."
Telix's Illuccix and Gozellix, after radiolabeling with 68Ga, are indicated for PET scanning of PSMA-positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy or those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels. The drugs are associated with potential adverse reactions such as nausea, diarrhea, and dizziness, with the risk of radiation exposure and the need for safe handling. Hypersensitivity reactions to sulfites may also occur.
The safety and efficacy of 68Ga-PSMA-PET imaging, as evaluated in the BiPASS study, could have far-reaching implications for prostate cancer management, potentially reducing unnecessary biopsies and improving patient outcomes. Successful implementation of BiPASS could broaden access to this advanced imaging technique across a larger patient population.