Study to assess combination of MRI and PSMA-PET for prostate cancer detection

The first patient has been dosed in the phase 3 BiPASS trial (NCT07052214), aimed at expanding the indications for Illuccix and Gozellix (kits for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection) to include use in prostate cancer diagnosis, Telix announced in a news release.¹

Illuccix and Gozellix are both currently approved in the US for patients with prostate cancer who have suspected metastases and are candidates for initial definitive therapy and patients who have suspected recurrence of prostate cancer based on an elevated serum prostate-specific antigen (PSA) level. Illuccix is also approved for selection of patients with metastatic prostate cancer who are indicated for prostate-specific membrane antigen (PSMA)-directed radioligand therapy (¹⁷⁷Lu-PSMA-617).

Specifically, the registrational BiPASS study will be assessing whether the combination of MRI and PSMA-PET imaging may improve sensitivity, specificity, and positive and negative predictive values in the diagnosis of prostate cancer. Investigators are hoping to determine if some patients can be selected to avoid a biopsy altogether or instead undergo a single PSMA-PET–guided biopsy.

The first patient in the trial was dosed under the supervision of Professor Tony Costello AM at the Australian Prostate Centre (APC) and imaged by Professor Rodney Hicks AM MBBS(Hons), MD, FRACP, FICIS, FAAHMS, of the Melbourne Theranostic Innovation Centre (MTIC). The patient’s biopsy was done by Phil Dundee, BSc, MBBS, FRACS(Urol), BiPASS investigator and clinical director of the APC.

“Urologists are often faced with the dilemma of whether or not to biopsy,” explained Costello, founder and director of APC, in the news release.¹ “This invasive and often painful procedure carries risks, with many men refusing it altogether. From a clinical perspective, when the biopsy shows low to intermediate risk cancer, it’s unclear whether this represents the true burden of disease or sampling error. Combining MRI and PSMA-PET imaging has the potential to improve both the patient experience and diagnostic accuracy. As such, being part of this study is very important to the APC and our patients.”

In total, the prospective, open-label, longitudinal trial plans to enroll 204 adult patients across approximately 25 clinical trial sites in the US and Australia.² Patients are eligible for enrollment if they have clinical suspicion of prostate cancer and undergo template biopsy. Patients are not eligible for the trial if they have had prior treatment for prostate cancer or received a prior diagnosis of clinically significant prostate cancer.

Those included in the study will undergo MRI and PSMA-PET scans before a standard 12 core anatomical (2 core six sectors) template biopsy. Those who present with clinically significant prostate cancer will proceed with therapy/management as per the institutional standard or according to clinician judgment.

Follow-up data in the study will be collected for up to 6 months to ensure that participants who were initially evaluated as negative on both imaging and histopathology are reliably negative.

The primary objective of the study is to evaluate the diagnostic performance of combined ⁶⁸Ga-PSMA-11 PET and MRI targeted biopsy for prostate cancer detection. Histological confirmation will be used at the standard of truth (SOT). The study’s co-primary end point is the sensitivity and specificity of ⁶⁸Ga-PSMA-11 PET as an adjunct to MRI for the detection of prostate cancer, confirmed by SOT.

Final completion of the study is expected in November 2026.

“PSMA-PET plus MRI has the potential to fundamentally change prostate cancer diagnosis,” added Hicks, founder, chair and chief medical officer at MTIC, in the news release.¹ “Using existing technologies with proven performance in lesion detection at the start of the patient journey could improve the way we stratify patients—safely de-escalating treatment or using a single precision biopsy for diagnosis.”

The BiPASS trial is looking to build on previous work from the PRIMARY and PRIMARY2 trials. These studies demonstrated the advantages of PSMA-PET in combination with MRI in defining or ruling out prostate cancer, or in selecting patients for active surveillance before an invasive biopsy.

Professor Louise Emmett, principal investigator for the PRIMARY trial and director of theranostics and nuclear medicine at St Vincent’s Hospital, said, “My colleagues and I have built a significant body of research on the benefits of PSMA-PET and MRI, documented in the PRIMARY studies, and we are pleased to see Telix expand on this research with this registration-enabling study. BiPASS has the potential to positively impact all men by changing clinical practice and guidelines to facilitate earlier, more accurate prostate cancer diagnosis.”

REFERENCES

1. Telix doses first patient in phase 3 BiPASS trial: PSMA-PET imaging for prostate cancer diagnosis. News release. Telix Pharmaceuticals. September 9, 2025. Accessed September 9, 2025. https://www.globenewswire.com/news-release/2025/09/09/3147425/0/en/Telix-Doses-First-Patient-in-Phase-3-BiPASS-Trial-PSMA-PET-Imaging-for-Prostate-Cancer-Diagnosis.html

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