Telix Expands Prostate Cancer Imaging With Phase 3 BiPASS Study

Telix Pharmaceuticals has completed enrollment of 350 patients in the Phase 3 BiPASS study (NCT07052214) evaluating ^68Ga-PSMA-11 PET/CT combined with MRI before prostate biopsy. The registrational study is assessing whether the imaging approach can improve detection of clinically significant prostate cancer, reduce unnecessary biopsies and better guide biopsy decisions, while Telix engages with the U.S. Food and Drug Administration (FDA) on a potential New Drug Application (NDA) pathway that could expand reimbursement and access to gallium-based PSMA-PET imaging.

Moving PSMA-PET Earlier in Prostate Cancer Diagnosis

BiPASS, short for Biopsy of the Prostate Avoidance Stratification Study, is evaluating the diagnostic performance of ^68Ga-PSMA-11 PET/CT used alongside MRI in men being assessed for prostate cancer before biopsy. The prospective, open-label Phase 3 trial enrolled 350 patients across the U.S. and Australia.

The study addresses a major limitation of the current diagnostic pathway. More than three million prostate biopsies are performed globally each year, yet up to 75% reportedly produce negative results. Biopsy can also cause pain, anxiety and complications, and approximately one in four patients declines a physician recommendation to undergo the procedure.

PSMA-PET adds functional information based on PSMA expression, while MRI provides detailed anatomic characterization of the prostate and surrounding structures. Combining the modalities could therefore help identify patients more likely to have clinically significant disease and refine decisions about whether and where to biopsy.

 Phase 3 Study Builds on Earlier Imaging Evidence

BiPASS builds on the PRIMARY and PRIMARY2 studies, which evaluated the combination of ^68Ga-PSMA-PET and MRI for prostate cancer detection. According to Telix, those studies showed improved detection of clinically significant prostate cancer while reducing unnecessary biopsies by almost 50%.

BiPASS is intended to determine whether those findings can support a registrational development program in the pre-biopsy setting. The supplied announcement describes the study’s goals in terms of improving diagnostic accuracy, reducing unnecessary biopsy procedures and improving biopsy targeting rather than specifying a single primary diagnostic metric such as negative predictive value or sensitivity.

Regulatory Pathway and Broader Access

Telix has aligned with the FDA on an NDA pathway for BiPASS. If supported by the Phase 3 results and subsequent regulatory review, the pathway could establish a new product reimbursement route and expand access to ^68Ga-PSMA-PET imaging to a substantially larger patient population.

Louise Emmett, Director of Theranostics and Nuclear Medicine at St Vincent’s Hospital and a BiPASS investigator, said the study could be particularly relevant for men with equivocal MRI findings. She pointed to the PRIMARY and PRIMARY2 data showing that adding PSMA-PET to MRI could substantially reduce biopsy use without missing clinically significant prostate cancer.

Safety Considerations for ^68Ga-Gozetotide Imaging

Illuccix and Gozellix are kits used to prepare gallium Ga 68 gozetotide for PET imaging. Illuccix is currently indicated for imaging PSMA-positive lesions in specified prostate cancer settings, including suspected metastasis, suspected recurrence based on elevated PSA and selection of patients for PSMA-directed therapy.

The prescribing information warns that gallium Ga 68 gozetotide uptake is not specific to prostate cancer. A negative scan does not exclude prostate cancer, while a positive scan does not independently confirm malignancy. Clinical correlation, including histopathologic evaluation when appropriate, remains important.

Across clinical studies, reported adverse reactions have included nausea, diarrhea and dizziness, generally at rates below 1%. Fatigue, nausea, constipation and vomiting were also reported in the VISION study. Gallium Ga 68 gozetotide contributes to cumulative radiation exposure, and patients are advised to hydrate and void frequently after administration.

Next Steps for BiPASS

With enrollment complete, Telix will advance the study toward analysis of the Phase 3 diagnostic data and the planned regulatory pathway. Positive results could support a broader role for ^68Ga-PSMA-11 PET/CT plus MRI in the initial diagnostic evaluation of prostate cancer, potentially helping clinicians identify which men require biopsy and where the procedure should be targeted.

Such an outcome would extend PSMA-PET beyond its current applications in prostate cancer staging and evaluation of suspected recurrence, while potentially reducing unnecessary invasive procedures and improving diagnostic decision-making.

Reference

Telix Completes Enrollment in Phase 3 BiPASS Study, Aligns with FDA on NDA Pathway – Telix Pharmaceuticals Limited | Telix Pharmaceuticals Limited