Telix has dosed the first U.S. patient in BiPASS, a prospective, open-label Phase 3 study evaluating whether adding 68Ga-PSMA-11 PET imaging (Illuccix or Gozellix) to MRI in men with elevated PSA can improve initial prostate cancer detection and safely reduce biopsies. The 250-patient trial spans sites in the U.S. and Australia and is designed to support the first marketing authorization for PSMA PET in the pre-biopsy setting.
The move pushes PSMA PET upstream from its current use in staging, biochemical recurrence, and therapy selection into the earliest point of diagnosis. The commercial rationale is straightforward: more than a million biopsies are conducted annually in the U.S., most of which are negative, and a sizable fraction of patients decline the procedure. Demonstrating that PET+MRI can de-escalate biopsy or increase precision when biopsy proceeds could materially expand utilization of Telix’s tracers while reframing the diagnostic algorithm that has been anchored in MRI and risk calculators.
Strategically, Telix is leveraging existing, widely distributed products to compress the path from evidence to adoption. Using Illuccix and Gozellix—already approved in other prostate cancer use cases—simplifies trial operations, aligns with current radiopharmacy supply chains, and positions the company for rapid commercial execution if the label expands. The trial also builds on the PRIMARY and PRIMARY2 evidence base suggesting that PSMA PET can refine risk stratification before invasive sampling, an approach that aligns with payer and guideline pressures to reduce low-yield procedures.
Operationally, BiPASS tests whether community urology practices and imaging centers can coordinate mpMRI and PET earlier in the pathway without adding friction. Success will depend on scheduling logistics, standardized interpretation across modalities, and clear thresholds for biopsy deferral versus targeted sampling. The endpoints that matter to regulators, guideline committees, and payers will hinge on clinical utility: avoidance of unnecessary biopsies without missing clinically significant disease, concordance with pathology, and actionable shifts in management, not just gains in sensitivity.
Competitive pressure is real. F-18 PSMA tracers (e.g., piflufolastat) and other Ga-68 agents could pursue similar indications, while noninvasive biomarker tests (4Kscore, ExoDx, SelectMDx, IsoPSA) are already entrenched as pre-biopsy triage tools. To change practice, PSMA PET must show incremental value over MRI plus biomarkers and present a sustainable health-economic story that offsets PET costs with avoided procedures and complications. There is also a clinical tension: moving PET earlier raises the risk of detecting indolent disease and demands disciplined interpretation to prevent overtreatment, alongside considerations of radiation exposure and benign uptake confounders.
For sites, a positive readout could shift volumes from template biopsies toward image-guided, transperineal targeting and increase demand for PET capacity and trained readers. Sponsors and CROs should expect more diagnostic utility trials with integrated health economics and centralized imaging reads, as regulators and payers scrutinize net benefit. Payers will look for robust negative predictive value and clear decision-impact metrics before broad coverage; coding and prior authorization flows will shape real-world adoption speed.
What to watch next: enrollment cadence across community and academic settings, the definition and magnitude of “biopsy avoidance” tied to clinically significant disease, and whether BiPASS includes cost and quality-of-life readouts that resonate with CMS and commercial payers. If the signal is strong, label expansion and guideline updates could follow, but uptake will hinge on reimbursement, workflow integration, and whether competitors reach the same indication first.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
