12/06/2026
Congratulations to Prof. Louise Emmett, Prof. Michael Hofman and collaborators on the publication of PRIMARY2 study results in The Lancet Oncology.
The investigator-initiated, randomized Phase 3 trial evaluated the addition of ⁶⁸Ga-PSMA-11 PET/CT to MRI in men with equivocal prostate MRI findings.
Results suggest that integrating gallium-based PSMA-PET with MRI could safely halve the number of these patients who need a biopsy for suspected prostate cancer.
Building on this study, Telix’s registration-enabling Phase 3 BiPASS™ trial is the first study designed to support marketing authorization for ⁶⁸Ga-PSMA-11 PET imaging in this setting. BiPASS incorporates the PRIMARY score, a validated reporting framework developed for the PRIMARY trials, as a key component of its imaging assessment methodology.
Prof. Emmett and other investigators are collaborating with Telix on BiPASS to determine whether combining MRI with Telix’s proprietary ⁶⁸Ga-PSMA-11 PET agents can improve diagnostic accuracy, enhance patient stratification and reduce unnecessary biopsies.
BiPASS is currently enrolling patients at sites in Australia and the United States.
Read the PRIMARY2 publication here: https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(26)00120-8
Learn more about BiPASS here: https://clinicaltrials.telixpharma.com/trial/bipass/