Study launches of MRI plus PSMA-PET imaging for prostate cancer detection

The first patient in the US has been dosed in the phase 3 BiPASS trial (NCT07052214), evaluating the earlier use of Illuccix (kit for the preparation of gallium Ga 68 gozetotide injection) and Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) for prostate cancer detection.¹

Specifically, the trial is seeking to determine whether combining MRI with molecular Illuccix/Gozellix ⁶⁸Ga-PSMA-11 PET imaging may improve diagnostic accuracy and reduce the need for biopsy in the initial prostate cancer diagnosis setting. The first dose in the trial was administered under the supervision of Brian Mazzarella, MD, a urologist at Urology Austin, an affiliate of Urology America.

“We’re excited to participate in the BiPASS trial at Urology Austin, which brings together promising technologies and emerging trends in patient care,” said Mazzarella, who is also the vice president of research for Urology America, in a news release from Telix.¹ “If BiPASS is successful in meeting its primary end point, it could eliminate the need for biopsy—reducing risks, side effects, and costs—and improve decision-making for providers and patients.”

According to Telix, “BiPASS is the first study designed to gain marketing authorization for ⁶⁸Ga-PSMA-PET imaging in the pre-biopsy setting.” The trial is supported by previous data from the PRIMARY and PRIMARY2 (NCT05154162) trials, which demonstrated that ⁶⁸Ga-PSMA-11 PET imaging plus MRI improved the negative predictive value and sensitivity for clinically significant prostate cancer vs MRI alone.”²

BiPASS is seeking to build on these findings. In total, the prospective, single-arm, open-label trial is planning to enroll 250 patients through clinical trials sites across the US and Australia. Patients are eligible for enrollment if they have a clinical suspicion of prostate cancer and will undergo a template biopsy based on either an initial MRI (PI-RADS 3 to 4) within 3 months prior to enrollment or no MRI evidence (PI-RADS 1 to 2) within 3 months prior to enrollment but a recommendation to proceed to biopsy based on non-imaging risk factors.³

The primary objective in the study is to assess the diagnostic performance of ⁶⁸Ga-PSMA-11 PET and MRI targeted biopsy for prostate cancer detection. Histopathology will be used as the standard of truth. The trial’s co-primary end point is to quantify the sensitivity and specificity of ⁶⁸Ga-PSMA-11 PET as an adjunct to MRI.

Follow-up will be collected for up to 6 months for patients with no baseline imaging or histopathological evidence of prostate cancer. The study is expected to reach final completion in November 2026.

“Illuccix and Gozellix are already transforming how clinicians treat and manage prostate cancer,” concluded Kevin Richardson, CEO of Telix Precision Medicine, in the news release.¹ “By initiating this trial, we are reinforcing Telix’s commitment to patient centricity, clinical innovation, and industry leadership—with the goal of eliminating invasive biopsy.”

REFERENCES

1. First U.S. patient dosed in BiPASS: Phase 3 prostate cancer diagnosis study. News release. Telix Pharmaceuticals Limited. January 16, 2026. Accessed January 20, 2026. https://telixpharma.com/news-views/first-u-s-patient-dosed-in-bipass-phase-3-prostate-cancer-diagnosis-study/

2. Emmett L, Buteau J, Papa N, et al. The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study. Eur Urol. 2021;80(6):682-689. doi:10.1016/j.eururo.2021.08.002

3. PSMA PET combined with MRI for the detection of PCa (BiPASS). ClinicalTrials.gov. Last updated September 10, 2025. Accessed January 20, 2026. https://clinicaltrials.gov/study/NCT07052214