Clarity Pharmaceuticals has unveiled compelling Phase II trial results showing its Cu-SAR-bisPSMA PET imaging agent significantly improves detection of prostate cancer recurrence over the current standard. The data, presented at the 2026 European Association of Urology Congress and accepted by European Urology journal, mark a key milestone ahead of regulatory submissions.
- Cu-SAR-bisPSMA detects 2.6 times more lesions than Ga-PSMA-11 in low PSA prostate cancer recurrence
- 78% of patients had positive scans with Cu-SAR-bisPSMA versus 36% with standard imaging
- Next-day imaging with Cu-SAR-bisPSMA changed patient management in 44% of cases
- Data accepted for publication in European Urology, impact factor 25.2
- Phase III AMPLIFY trial nearing completion to support FDA market authorisation
A Step Forward in Prostate Cancer Imaging
Clarity Pharmaceuticals (ASX:CU6) has taken a significant stride in prostate cancer diagnostics with the presentation of its Phase II Co-PSMA trial data at the prestigious European Association of Urology (EAU) Congress 2026 in London. The trial compared Clarity’s novel Cu-SAR-bisPSMA PET imaging agent against the current standard-of-care Ga-PSMA-11 in detecting biochemical recurrence of prostate cancer in patients with low prostate-specific antigen (PSA) levels.
The results, which have also been accepted for publication in the high-impact European Urology journal, demonstrate that Cu-SAR-bisPSMA substantially outperforms Ga-PSMA-11. Notably, Cu-SAR-bisPSMA identified 2.6 times more lesions on average per patient and detected disease recurrence in 78% of participants, compared to just 36% with the standard imaging agent.
Clinical Impact and Patient Management
Beyond improved detection, the trial revealed that next-day imaging with Cu-SAR-bisPSMA led to changes in clinical management for 44% of patients, primarily shifting treatment plans from surveillance to targeted radiotherapy. This suggests the agent’s potential to directly influence therapeutic decisions and improve patient outcomes.
Professor Louise Emmett, the trial’s principal investigator from St Vincent’s Hospital Sydney, emphasised the importance of head-to-head comparisons in guiding clinical choices. She highlighted that Cu-SAR-bisPSMA’s enhanced imaging performance could enable more personalised treatment strategies for men experiencing prostate cancer recurrence.
Building on a Strong Scientific Foundation
Clarity’s Executive Chairperson, Dr Alan Taylor, praised the rigorous scientific approach underpinning the development of Cu-SAR-bisPSMA. He noted the synergy between academic research and clinical application, referencing prior foundational studies on the SAR chelator technology that securely binds copper isotopes, preventing leakage and enabling precise imaging and therapy.
The Co-PSMA data complements findings from the Phase II COBRA trial and supports the ongoing Phase III AMPLIFY registrational study, which recently completed enrolment. Together, these trials form the basis for planned submissions to the US Food and Drug Administration (FDA) seeking market authorisation for Cu-SAR-bisPSMA as a diagnostic tool for biochemical recurrence of prostate cancer.
Looking Ahead
Prostate cancer remains a leading cause of cancer death among men globally, with early and accurate detection of recurrence critical to improving survival. Clarity’s advancements in targeted copper theranostics position it at the forefront of this evolving field. As the company prepares to engage with regulatory authorities, the medical community will be watching closely to see if Cu-SAR-bisPSMA can deliver on its promise to transform prostate cancer management.
Bottom Line?
Clarity’s Cu-SAR-bisPSMA is poised to redefine prostate cancer imaging, but final Phase III results and regulatory approval will be decisive.
Questions in the middle?
- Will the Phase III AMPLIFY trial confirm the superior diagnostic performance of Cu-SAR-bisPSMA?
- How quickly might the FDA grant market authorisation based on the combined trial data?
- What impact will improved lesion detection have on long-term patient survival and treatment costs?