A new prostate cancer imaging technology from Clarity Pharmaceuticals (ASX:CU6) is showing promise in improving the detection of recurrent disease, after results from a comparative clinical study indicated it may outperform the current standard of care.
The company announced that findings from the Co-PSMA investigator-initiated trial, led by Professor Louise Emmett at St Vincent’s Hospital, Sydney, reveal its diagnostic product, copper-64 SAR-bisPSMA, detected more than twice as many prostate cancer lesions as the commonly used gallium-68 PSMA-11 scan in men with biochemical recurrence following surgery.
The Phase 2 study enrolled 50 patients whose prostate-specific antigen levels suggested a return of disease but remained relatively low, a group where detection is often difficult. Participants underwent both scans within a three-week window, allowing researchers to directly compare performance under controlled conditions.
The copper-based scan identified an average of 1.26 lesions per patient, compared with 0.48 lesions detected by the standard scan, a statistically significant difference. Across the full study population, the new imaging method detected 63 lesions, while the existing approach identified just 24. At the patient level, the experimental scan showed positive results in 78 per cent of men, compared with 36 per cent with the current standard.
Perhaps most clinically meaningful, the additional information altered planned treatment decisions in 44 per cent of participants, highlighting the potential downstream impact of earlier and more precise disease localisation.
Researchers say the findings reinforce growing evidence that the SAR-bisPSMA platform may offer a more sensitive way to detect prostate cancer recurrence, particularly at low PSA levels where conventional PSMA imaging agents can struggle to reveal disease.
Clarity’s leadership believes the data strengthen the case that improved diagnostics could shift treatment pathways. Earlier identification of recurrent lesions may allow clinicians to intervene with targeted therapies sooner, potentially reducing the need for systemic treatments and improving patient outcomes.
The results have been accepted for oral presentation at the 2026 European Association of Urology Congress in London, one of the field’s largest global meetings, where additional data from the study is expected to be released.