The FDA has granted Fast Track designation to BiPASS, Telix Pharmaceuticals’ program evaluating gallium-68 PSMA PET combined with MRI before prostate biopsy. The announcement, made by the Australian company and reported by Diagnostic Imaging on September 30, follows the publication of the randomized PRIMARY2 trial in The Lancet Oncology, in which adding PSMA PET/CT let 49% of men with equivocal or non-suspicious MRI avoid biopsy without losing detection of clinically significant cancer.
What the FDA granted and what BiPASS is
BiPASS stands for Biopsy of the Prostate Avoidance Stratification Study. The open-label, single-arm phase 3 study (NCT07052214) uses Telix’s PSMA PET agents Illuccix and Gozellix, both kits for preparing gallium-68 gozetotide (the PSMA-11 molecule), alongside MRI, with histopathology from targeted biopsy as the standard of truth. The ClinicalTrials.gov record lists an estimated 338 participants, sites mostly in the United States plus two in Australia, and co-primary endpoints of sensitivity and specificity measured at 12 months. The company says enrollment is complete.
Fast Track is an FDA mechanism for drugs that treat serious conditions with an unmet medical need. In practice it brings more frequent meetings with the agency and allows rolling review of the application. Telix says it has agreed with the FDA on a new drug application (NDA) pathway, rather than a label expansion, and is preparing the submission. One point matters here: Illuccix and Gozellix are already approved in the US for initial staging of patients with suspected metastasis and for suspected biochemical recurrence, but pre-biopsy use remains investigational everywhere.
In the release, group chief medical officer David N. Cade said the designation reflects recognition of an unmet need in the diagnostic pathway and that PSMA PET used alongside MRI could help physicians make better-informed decisions before biopsy and cut unnecessary invasive procedures. The company notes that more than three million prostate biopsies are performed worldwide each year and that up to 75% come back negative.
The numbers from PRIMARY and PRIMARY2
BiPASS rests on two Australian studies. The first, PRIMARY, published in European Urology in 2021 by Louise Emmett and colleagues, included 291 men who underwent MRI, pelvic PSMA PET/CT and biopsy. Combined PSMA + MRI raised the negative predictive value for clinically significant cancer from 72% to 91% and sensitivity from 83% to 97%, at the cost of lower specificity (40% vs 53%).
The second, PRIMARY2, led by James P. Buteau of the Peter MacCallum Cancer Centre, appeared in The Lancet Oncology (2026;27:839-848). Across seven Australian hospitals, 660 biopsy-naive men with PI-RADS 2 (51%) or PI-RADS 3 (49%) MRI and at least one high clinical risk factor (PSA density above 0.1 ng/mL/mL, strong family history, abnormal digital rectal exam, BRCA mutation and others) were randomized 1:1 to systematic transperineal biopsy or PSMA PET/CT. In the experimental arm, men with a PRIMARY score of 3 to 5 underwent PET-targeted biopsy; those scoring 1 or 2 entered PSA surveillance.
The results: 163 of 331 participants (49%) avoided biopsy at six months. Detection of clinically significant cancer (Gleason 3+4 with at least 10% pattern 4) was 12% in the PET arm and 16% in controls, a -3.7 percentage-point difference within the 10% non-inferiority margin. Detection of insignificant cancer fell from 32% to 14%. The authors list as limitations the lack of a consensus definition of significant disease and more withdrawals without biopsy in the control arm.
Technical context: why PET complements MRI
Multiparametric MRI has become the front door of prostate diagnosis, but PI-RADS 3 cases are a gray zone, and high-risk men with PI-RADS 2 are often biopsied anyway for fear of a false negative. As we reported when noting that pre-biopsy MRI is used in just a third of US cases, even the first step of the pathway is not universal. PSMA PET adds molecular information: PSMA is overexpressed in higher-grade tumors, and the five-point PRIMARY score combines the intraprostatic uptake pattern with intensity (SUVmax) to grade the likelihood of significant disease.
There are logistical implications. Gallium-68 has a half-life of about 68 minutes and comes from germanium-68/gallium-68 generators or cyclotron production, which limits doses per elution and requires a nearby radiopharmacy. Widespread pre-biopsy use would mean far more PET demand than today’s, which is concentrated in staging and recurrence.
Implications for radiology, nuclear medicine and radiotherapy
If approved, an imaging-first pathway would push radiologists and nuclear medicine physicians into the same decision, with structured reports combining PI-RADS and PRIMARY score. For radiation oncology the benefit is indirect but real: patients diagnosed by PSMA-targeted biopsy reach planning with a dominant lesion already characterized on two modalities, which helps target volume delineation and focal boost decisions. The debate on MRI’s role in staging, covered in our story on how MRI could replace digital exams in prostate staging, now gains a molecular layer.
In Brazil and much of Latin America, PSMA PET is available at private and academic nuclear medicine services, mainly for staging and recurrence; pre-biopsy use has no regulatory backing or known reimbursement. The screening debate, including the Cochrane shift toward supporting prostate screening, still runs into limited access to MRI itself in many regions.
Outlook and limitations
Fast Track is not approval: it speeds up regulatory dialogue, but the NDA will depend on BiPASS data that have not yet been released. PRIMARY2 was run at experienced Australian centers with follow-up still ongoing, and the authors themselves call for cost-effectiveness analyses and validation with other PSMA radiopharmaceuticals. How men who skipped biopsy fare in the long term is also unknown. Telix, which we covered for its girentuximab PET in renal tumors, is betting on expanding Ga-68 PSMA into a much larger population; the challenge will be showing that the clinical gain justifies the cost and logistics.
Source: Diagnostic Imaging, Telix press release and Buteau et al., Lancet Oncology 2026
