Telix Launches Phase 3 Trial to Challenge Prostate Biopsy Standard

Event summary

  • First U.S. patient dosed in BiPASS Phase 3 trial on January 16, 2026
  • Study aims to enroll 250 patients across U.S. and Australian sites
  • Trial evaluates Illuccix and Gozellix PSMA-PET imaging for pre-biopsy prostate cancer diagnosis
  • Objective: Reduce unnecessary biopsies with non-invasive imaging
  • Illuccix approved globally, Gozellix approved by U.S. FDA but neither approved for initial diagnosis

The big picture

Telix's BiPASS trial targets a significant unmet need in prostate cancer diagnosis, where up to 75% of U.S. biopsies prove negative annually. The study represents a strategic push to validate non-invasive imaging as a replacement for invasive procedures, potentially transforming diagnostic workflows. Success could position Telix as a leader in precision oncology diagnostics, with implications for both patient care and healthcare cost reduction.

What we're watching

Regulatory Pathway
Whether BiPASS success could lead to first marketing authorization for 68Ga-PSMA-PET in pre-biopsy setting
Market Expansion
The pace at which Telix can expand precision imaging access if trial meets primary objectives
Competitive Positioning
How this positions Telix against competitors in prostate cancer diagnostics

Related topics

Oncology