Telix Pharmaceuticals has completed enrolment in its pivotal BiPASS trial, moving the Australian company closer to testing whether its gallium-based PSMA PET imaging agents can help determine which men with suspected prostate cancer need a biopsy in the first place.
The 350-patient Phase 3 study, conducted in the United States and Australia, is examining the diagnostic value of combining MRI with Telix’s Illuccix and Gozellix PSMA PET imaging agents before biopsy. The company said it has also aligned with the US Food and Drug Administration on a New Drug Application pathway that could, if the study is successful and the application approved, establish a new reimbursable use for the products.
That would mark a potentially important expansion for PSMA PET, which is currently used chiefly to stage prostate cancer after diagnosis and to assess suspected recurrence. Telix is seeking to establish a role for the technology much earlier in the patient pathway, when clinicians decide whether an invasive tissue biopsy is warranted.
Telix describes the Biopsy of the Prostate Avoidance Stratification Study, known as BiPASS, as the first registrational trial of gallium-68 PSMA PET imaging in the pre-biopsy setting. It will assess whether adding PSMA PET and CT to MRI improves detection of clinically significant cancer, reduces avoidable biopsies, or helps clinicians better target biopsies that do proceed.
The commercial opportunity lies in the size and inefficiency of the existing diagnostic pathway. Telix says more than three million prostate biopsies are performed each year globally, despite estimates that up to three-quarters return a negative result. Biopsy can be painful and anxiety-provoking, carries a risk of complications and remains an obstacle for some patients, with the company citing evidence that about one in four men decline a clinician’s recommendation to undergo the procedure.
The clinical premise behind BiPASS has already been explored in the PRIMARY and PRIMARY2 studies, which examined the use of gallium-68 PSMA PET alongside MRI in men undergoing investigation for prostate cancer. Telix said those studies indicated that the combined imaging approach could improve the detection of clinically significant disease while reducing unnecessary biopsies by almost half.
Professor Louise Emmett, director of theranostics and nuclear medicine at St Vincent’s Hospital and a BiPASS investigator, said the milestone was particularly relevant for men whose MRI findings are uncertain.
“The PRIMARY and PRIMARY2 studies demonstrated that gallium-68 PSMA PET, when used alongside MRI, can safely halve the number of biopsies required without missing clinically significant prostate cancer,” Professor Emmett said. “BiPASS now has the potential to fundamentally change the current standard of care, streamlining the diagnostic pathway, accelerating treatment decision-making and helping to ensure that men receive the most appropriate therapy earlier in their treatment journey.”
The argument for pairing the modalities is that MRI offers detailed anatomical information while PSMA PET can provide functional evidence of disease activity. Dr Brian Mazzarella, vice-president of research at Urology America and a BiPASS investigator, said that combination could support more informed diagnostic decisions and reduce patient exposure to procedures that may not be needed.
Telix said its discussions with the FDA had identified an NDA route that would support reimbursement as a new product indication, rather than relying solely on the existing uses of Illuccix and Gozellix. A successful filing could therefore open a substantially larger addressable population than the current staging and recurrence markets.
Dr David Cade, Telix’s group chief medical officer, said rapid recruitment reflected interest among clinicians and patients in a more accurate and less invasive diagnostic pathway. He said the company believed advanced imaging could shift the clinical question from how best to stage confirmed prostate cancer to which men should undergo biopsy at all.
