Enrollment goal met in phase 3 study of 68Ga-PSMA-PET in pre-biopsy setting

The target enrollment has been met in the phase 3 BiPASS study, evaluating earlier use of gallium-68 (⁶⁸Ga) prostate-specific membrane antigen (PSMA)-11 PET in combination with prostate MRI in the pre-biopsy setting.¹

Telix Pharmaceuticals announced that 350 patients had been enrolled at sites across the US and Australia. The company also said it has engaged with the FDA regarding a potential New Drug Application (NDA) pathway based on the BiPASS program.

The study is evaluating ⁶⁸Ga-PSMA-11 PET/CT using Telix’s Illuccix and Gozellix imaging agents, which are currently approved in the US for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. Illuccix is also indicated for the selection of patients for PSMA-directed therapy.

“PSMA-PET imaging with tracers such as Illuccix and Gozellix has already changed how we stage and manage prostate cancer,” said Brian Mazzarella, MD, FACS, vice president of research for Urology America and BiPASS investigator, in a news release from Telix.¹ “By combining the functional information from PSMA-PET with the detailed anatomic information provided by MRI, we have an unprecedented opportunity to improve the detection of clinically significant prostate cancer and guide more informed diagnostic decisions. For patients, this approach has the potential to reduce unnecessary procedures, lower procedural risk, ease anxiety, and ultimately enable more precise, individualized treatment decision-making.”

Trial overview

BiPASS (NCT07052214) is a prospective, open-label, phase 3 study designed to evaluate the diagnostic performance of ⁶⁸Ga-PSMA-11 PET when added to MRI for the detection of prostate cancer. The study is evaluating whether combining the 2 imaging modalities can improve detection of clinically significant prostate cancer (csPCa), reduce unnecessary biopsies, or better direct biopsy toward suspicious lesions compared with current standard practice.

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 1 to 4) within 6 months prior to enrollment and/or non-imaging risk factors.² Participants must also have an ECOG performance status of 2 or lower per FDA guidelines.

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.

The study is expected to reach final completion in April 2027.

Clinical context

According to Telix, the trial builds on the clinical foundation established by the PRIMARY and PRIMARY2 (NCT05154162) trials, which demonstrated that the addition of ⁶⁸Ga-PSMA-11 PET/CT reduced unnecessary biopsies by 49% (95% CI, 44 to 55; P < .0001) without reducing the detection of csPCa (difference –3.7%; 95% CI, –8.9 to 1.5%; P = .0093).^3,4

Related: PRIMARY2: PSMA-PET/CT can safely reduce prostate biopsies in men with equivocal MRI

“Completing patient enrollment in BiPASS is an important milestone for men with suspected prostate cancer, particularly those with equivocal MRI findings. The PRIMARY and PRIMARY2 studies demonstrated that ⁶⁸Ga-PSMA-PET, when used alongside MRI, can safely halve the number of biopsies required without missing clinically significant prostate cancer,” said Louise Emmett, MD, PhD, MBChB, FRACP, director of theranostics and nuclear medicine at St Vincent’s Hospital and BiPASS investigator, in the news release.¹ “BiPASS now has the potential to fundamentally change the current standard of care, streamlining the diagnostic pathway, accelerating treatment decision-making, and helping to ensure that men receive the most appropriate therapy earlier in their treatment journey.”

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