How Clarity’s Cu-64 SAR-bisPSMA Doubled Prostate Cancer Lesion Detection

A Breakthrough in Prostate Cancer Imaging

Clarity Pharmaceuticals has unveiled compelling results from its Co-PSMA Investigator-Initiated Trial (IIT), demonstrating that its Cu-64 SAR-bisPSMA diagnostic agent significantly outperforms the current standard Ga-68 PSMA-11 in detecting prostate cancer recurrence. Conducted at St Vincent’s Hospital Sydney under the leadership of Professor Louise Emmett, the Phase II trial compared the two agents in 50 patients experiencing biochemical recurrence after radical prostatectomy.

The trial’s headline finding is striking – Cu-64 SAR-bisPSMA identified an average of 1.26 lesions per patient, more than double the 0.48 lesions detected by Ga-68 PSMA-11. In total, Cu-64 SAR-bisPSMA detected 63 lesions across participants, compared to just 24 by the standard agent. This translated into a positive scan rate of 78% for Cu-64 SAR-bisPSMA, more than twice the 36% rate for Ga-68 PSMA-11.

Clinical Impact and Patient Management

Beyond the numbers, the improved detection had tangible clinical consequences. Nearly half (44%) of the patients had their treatment plans altered based on the Cu-64 SAR-bisPSMA imaging results. This suggests that the enhanced sensitivity of Clarity’s agent could enable earlier and more targeted interventions, potentially improving patient outcomes by catching recurrent disease sooner and more accurately.

Professor Emmett highlighted the challenge with existing PSMA PET agents, which, while highly specific, often miss lesions at low PSA levels, complicating treatment decisions. Cu-64 SAR-bisPSMA’s ability to detect disease in a higher proportion of patients at these early stages marks a significant advancement in prostate cancer diagnostics.

Positioning in a Growing Market

Clarity’s Executive Chairperson, Dr Alan Taylor, emphasised the broader market implications. The US PSMA PET imaging market alone is valued at around US$2 billion annually and is expected to exceed US$3 billion by 2029. Currently dominated by agents with limited sensitivity, Clarity’s dual-targeting SAR-bisPSMA technology offers a differentiated approach that could redefine the standard of care.

The company’s SAR technology securely holds copper isotopes, enabling both diagnostic imaging with Cu-64 and potential therapeutic applications with Cu-67. This theranostic capability positions Clarity uniquely in the radiopharmaceutical landscape.

Next Steps and Regulatory Outlook

The Co-PSMA data will be presented in full at the European Association of Urology Congress in March 2026, providing a global platform for peer review and clinical discussion. Meanwhile, Clarity is advancing two registrational trials, AMPLIFY and CLARIFY, which are nearing recruitment completion and will be critical for regulatory approval and commercialisation.

Significantly, Cu-64 SAR-bisPSMA remains an unregistered product and has not yet received approval from regulatory bodies such as the US FDA or Australia’s TGA. Market adoption will depend on successful trial outcomes, regulatory clearances, and reimbursement pathways.

Nevertheless, the Co-PSMA trial results add to a growing body of evidence supporting Cu-64 SAR-bisPSMA’s superior diagnostic performance and its potential to transform prostate cancer management.