Clarity Pharma’s Cancer Scanner Detects 2x More Tumours, 44% Change Treatment
Clarity Pharmaceuticals (ASX: CU6) has announced the Clarity Pharmaceuticals SAR-bisPSMA Publication in European Urology, the official journal of the European Association of Urology (EAU) Congress 2026 with an impact factor of 25.2. The Co-PSMA trial results provide the first comparative evidence that 64Cu-SAR-bisPSMA significantly outperforms current standard of care imaging, detecting more than double the number of cancer lesions per patient and triggering treatment changes in 44% of participants.
Clarity Pharmaceuticals’ SAR-bisPSMA achieves landmark publication in leading urology journal
The Co-PSMA trial results are now published in European Urology, the official journal of the European Association of Urology (EAU) Congress 2026, which carries an impact factor of 25.2. This represents the first comparative evidence demonstrating that 64Cu-SAR-bisPSMA significantly outperforms the current standard of care in detecting prostate cancer recurrence.
The trial enrolled 50 patients with biochemical recurrence following radical prostatectomy, all with low prostate-specific antigen (PSA) levels ranging from 0.2 to 0.75 ng/mL. These patients are candidates for curative salvage therapy, where early and accurate lesion detection can directly influence treatment decisions and long-term outcomes.
64Cu-SAR-bisPSMA (next-day imaging at 24 hours post-injection) identified more than double the mean lesions per patient compared to 68Ga-PSMA-11 standard imaging (1.26 vs 0.48, p < 0.0001). This translated to 78% of participants showing positive scans with the SAR-bisPSMA agent, compared to just 36% with standard imaging. The patient-level true positive rate favoured 64Cu-SAR-bisPSMA at 71% versus 29% for 68Ga-PSMA-11.
Gianluca Giannarini (MD), Associate Editor of European Urology
“This prospective phase II trial provides the first comparative evidence that 24-hour 64Cu-SAR-bisPSMA positron emission tomography (PET) / computed tomography (CT) significantly outperforms 68Ga-PSMA-11 PET/CT in detecting tumour deposits in men with early biochemical recurrence (BCR) after radical prostatectomy, with more than double the per-patient detection rate and substantially lower false-negative findings. Importantly, the increased detection rate translated into a 44% management change rate, underscoring the real-world therapeutic impact of improved lesion detection at low prostate-specific antigen (PSA) levels. For the uro-oncology community, these data suggest that delayed imaging with a bivalent prostate-specific membrane antigen (PSMA) ligand may redefine the diagnostic pathway in early biochemical recurrence, potentially enabling more precise and timely salvage treatment strategies.”
Publication in a top-tier peer-reviewed journal validates the clinical differentiation of SAR-bisPSMA and strengthens both the regulatory and commercial pathway ahead of New Drug Application (NDA) submissions.
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How SAR-bisPSMA detected twice as many cancer lesions as standard imaging
The Co-PSMA trial was a head-to-head comparison of 64Cu-SAR-bisPSMA (next-day imaging at 24 hours) versus 68Ga-PSMA-11 in the same 50 patients. All scans were acquired on the same digital PET camera, with a median interval of just 2 days between imaging sessions (interquartile range: 1 to 8 days). This short interval rules out disease progression as a confounding factor.
The trial met its primary endpoint with statistical significance. 64Cu-SAR-bisPSMA identified a total of 63 lesions across all participants, compared to 24 with standard imaging. The mean lesions per patient were 1.26 versus 0.48, respectively (p < 0.0001).
| Metric | 64Cu-SAR-bisPSMA | 68Ga-PSMA-11 |
|---|---|---|
| Mean lesions per patient | 1.26 | 0.48 |
| Total lesions detected | 63 | 24 |
| Positive scan rate | 78% | 36% |
| True positive rate | 71% | 29% |
The superior performance was supported by improved imaging characteristics. At 24 hours, 64Cu-SAR-bisPSMA demonstrated higher lesion uptake (median maximum standardised uptake value 13.6 vs 5.3) and significantly lower background bladder activity (median SUVmax 12.0 vs 34.5). This improved tumour-to-background contrast enabled better visualisation of the prostate fossa, which is critical for detecting low-volume local recurrence.
Reader agreement was near-perfect for 64Cu-SAR-bisPSMA scans (Cohen’s Kappa 0.94) compared to moderate agreement for 68Ga-PSMA-11 (Cohen’s Kappa 0.75). This means the three independent blinded readers reached the same conclusions far more frequently when assessing SAR-bisPSMA images.
Statistical significance (p < 0.0001) provides robust clinical evidence supporting regulatory submissions and competitive positioning against established PSMA imaging agents.
Why imaging performance matters in early-stage prostate cancer detection
Biochemical recurrence occurs when PSA levels rise after radical prostatectomy, indicating potential cancer return. However, lesions at this stage are often too small for standard imaging to detect, particularly when PSA levels remain low (between 0.2 and 0.75 ng/mL, as in the Co-PSMA trial).
Current PSMA PET imaging frequently fails to visualise lesions at these low PSA levels, delaying treatment decisions. This creates a diagnostic gap where oncologists know cancer has returned biochemically but cannot locate it anatomically. Without knowing where the cancer is, clinicians often resort to observation or empirical treatment of broader areas.
Earlier, more accurate detection enables “curative salvage therapy,” which refers to treatment that can potentially cure the cancer before it spreads beyond the local area. This can include targeted radiation to specific lesions identified on imaging, rather than broader radiation fields or systemic therapy.
The unmet need in early biochemical recurrence represents a large patient population where current imaging underperforms, creating a clear market opportunity for superior diagnostics.
Superior imaging translates to real-world treatment changes
Imaging performance only matters if it changes clinical decisions. The Co-PSMA trial demonstrated that 44% of patients had planned management changes following 64Cu-SAR-bisPSMA imaging, compared to the treatment plan based on 68Ga-PSMA-11 results.
The two most common treatment modifications were:
- 12 of 22 patients changed from observation to active treatment
- 9 of 22 patients had radiation field modifications
Active planned management increased from 66% based on 68Ga-PSMA-11 results to 90% based on 64Cu-SAR-bisPSMA findings. This shift reflects the direct clinical utility of more accurate lesion detection, enabling oncologists to move from “wait and watch” strategies to targeted interventions.
The imaging advantages of 64Cu-SAR-bisPSMA contributed to these outcomes. Higher lesion uptake (SUVmax 13.6 vs 5.3), lower bladder background activity (SUVmax 12.0 vs 34.5), and near-perfect reader agreement (Cohen’s Kappa 0.94 vs 0.75) all support more confident clinical decision-making.
Management change rates directly demonstrate clinical utility, which is a key factor for both regulatory approval pathways and commercial adoption by oncologists.
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Commercial pathway advances toward blockbuster PSMA PET market
The company has received three Fast Track Designations from the US Food and Drug Administration (FDA) for the single SAR-bisPSMA agent. Fast Track Designation is granted to therapies that address unmet medical needs in serious conditions and is designed to facilitate development and expedite regulatory review.
Clarity is awaiting data from the registrational Phase III AMPLIFY trial and is nearing completion of recruitment into the pivotal CLARIFY study. These trials are required to support New Drug Application (NDA) submissions to the FDA.
The company’s manufacturing and supply strategy is positioned to provide over 2 million doses of copper-64 per year at base capacity for commercial launch. This exceeds two times the total addressable market for PSMA PET imaging and provides operational readiness for scale.
Dr Alan Taylor, Executive Chairperson, Clarity Pharmaceuticals
“SAR-bisPSMA is an outstanding agent, developed from the benchtop of Australian science with the clinical data now gaining significant momentum as we approach commercialisation… Our supply and manufacturing strategy is also positioned to provide over 2 million doses of copper-64 per year at base capacity for commercial launch, which is over two times the total addressable market for PSMA PET, and we are continuing to build added capacity to facilitate efficiencies throughout the entirety of the US.”
Key milestones ahead include:
- AMPLIFY: Registrational Phase III trial (data pending)
- CLARIFY: Pivotal study nearing recruitment completion
- NDA submissions planned following trial completions
- Manufacturing capacity: 2+ million doses annually at base capacity
Fast Track Designation accelerates FDA review timelines, while manufacturing scale demonstrates operational readiness for commercial launch into a blockbuster market opportunity.
What comes next for Clarity’s prostate cancer pipeline
The SAR-bisPSMA clinical program includes multiple completed trials that de-risk the platform: PROPELLER (completed), COBRA (completed), and Co-PSMA (completed). Two pivotal trials remain in progress: AMPLIFY (Phase III ongoing) and CLARIFY (recruiting).
The same SAR-bisPSMA platform enables theranostic potential. Copper-64 is used for diagnostic imaging, whilst copper-67 can be used for therapy. This “see it, treat it” approach with the same targeting molecule offers the potential to diagnose and treat using a single agent, rather than separate imaging and therapeutic products.
Near-term catalysts include AMPLIFY data and CLARIFY completion, which are required for regulatory filing and potential approval. Multiple completed trials de-risk the platform, whilst pending Phase III data represents the primary catalyst for regulatory filing and potential approval.
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