Breakthrough Co-PSMA Trial Results Unveiled at EAU Congress 2026

Introduction

On March 16, 2026, at the European Association of Urology (EAU) Congress in London, significant advancements in prostate cancer diagnostics were highlighted through an oral presentation by Professor Louise Emmett from St Vincent's Hospital, Sydney. This presentation detailed the key findings from the Co-PSMA (NCT06907641) Investigator-Initiated Trial (IIT). Moreover, the trial data was accepted for publication in the highly esteemed European Urology journal, emphasizing its notable impact on the field.

Background

The Co-PSMA trial evaluated Clarity Pharmaceuticals's innovative product, 64Cu-SAR-bisPSMA, in comparison with the standard-of-care 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) in men experiencing biochemical recurrence (BCR) of prostate cancer. Approximately 50 patients with low prostate-specific antigen (PSA) levels were assessed, focusing on their candidacy for curative salvage therapy following significant surgical intervention known as radical prostatectomy.

Trial Findings

The primary objective of the study was to analyze the average number of lesions detected per patient between the two imaging methods. Notably, 64Cu-SAR-bisPSMA demonstrated superior diagnostic performance. The results indicated that, on average, patients had a greater number of identifiable lesions with 64Cu-SAR-bisPSMA than with 68Ga-PSMA-11 (1.26 vs. 0.48). This statistical difference was recorded with a p-value of less than 0.0001, indicating a significant advantage.

Moreover, next-day imaging with 64Cu-SAR-bisPSMA allowed for the identification of 63 lesions opposed to just 24 utilizing 68Ga-PSMA-11. Remarkable improvements were recorded in prostate fossa and lymph nodes, with 64Cu-SAR-bisPSMA resulting in 78% of trial participants displaying positive scans, in contrast to 36% with the standard imaging. This underscores the enhanced sensitivity of 64Cu-SAR-bisPSMA, which showed a true positive rate of 71% and a marked reduction in false negatives (21% vs. 65%).

Management Impact

The implications for patient management were substantial. Following the trial imaging analysis, 44% of participants (22 out of 50) experienced a change in management strategy, primarily shifting from surveillance to a more aggressive treatment approach involving targeted radiotherapy. This demonstrates the potential for 64Cu-SAR-bisPSMA to directly influence treatment decisions in a clinical setting.

Future Directions

The results from the Co-PSMA trial, in conjunction with data from the ongoing Phase II COBRA trial and expected outcomes from the pivotal Phase III AMPLIFY study, mark significant milestones for Clarity Pharmaceuticals. These findings aim to be submitted to the U.S. Food and Drug Administration (FDA) for market authorization of 64Cu-SAR-bisPSMA, specifically for patients dealing with BCR of prostate cancer.

Conclusion

The Co-PSMA study's results are a triumph for Clarity Pharmaceuticals and the broader medical community. The evidence presented underscores the effectiveness of 64Cu-SAR-bisPSMA in improving the detection of prostate cancer compared to existing standard processes. With prostate cancer remaining a prevalent concern, advancements like these hold promise for improved patient outcomes and more personalized therapeutic strategies. The commitment to developing innovative treatment solutions for cancer patients is exemplified in Clarity's ongoing efforts, bringing hope to many who face this formidable disease.