Clarity Pharmaceuticals Completes Recruitment for Game-Changing Prostate Cancer Imaging Trial

Trial Recruitment Milestone

Clarity Pharmaceuticals (ASX, CU6) has announced the successful completion of patient recruitment for its Co-PSMA Phase II imaging trial, a critical step in evaluating its innovative diagnostic agent Cu-SAR-bisPSMA. Led by Professor Louise Emmett at St Vincent’s Hospital Sydney, the study enrolled 50 men experiencing biochemical recurrence of prostate cancer with low prostate-specific antigen (PSA) levels, a group where early and accurate detection is particularly challenging.

The trial directly compares Cu-SAR-bisPSMA to the current standard-of-care imaging agent Ga-PSMA-11, aiming to determine which provides superior detection of recurrent cancer lesions. This head-to-head approach is designed to address a significant unmet need, many patients with rising PSA after prostatectomy show no visible disease on existing scans, complicating treatment decisions.

Innovative Diagnostic Technology

Cu-SAR-bisPSMA leverages Clarity’s proprietary sarcophagine (SAR) technology to securely bind copper isotopes, enabling both diagnostic imaging with copper-64 and potential therapeutic applications with copper-67. Unlike other chelators, SAR technology prevents copper leakage, enhancing safety and imaging quality. The longer half-life of copper-64 compared to gallium-68 allows for delayed imaging, improving lesion contrast and detection sensitivity.

Previous clinical trials, PROPELLER and COBRA, have demonstrated encouraging results for Cu-SAR-bisPSMA, showing higher lesion uptake and retention compared to standard imaging. These findings have paved the way for the current Co-PSMA trial and two ongoing Phase III registrational studies, CLARIFY and AMPLIFY, which aim to further validate the technology in different clinical settings.

Clinical and Market Implications

Early and precise localisation of recurrent prostate cancer is crucial for guiding curative salvage therapies and improving patient outcomes. Dr Alan Taylor, Clarity’s Executive Chairperson, highlighted the high volume of patients imaged recently as evidence of the pressing demand for more sensitive diagnostic tools. Professor Emmett emphasized that improved imaging sensitivity could enable earlier intervention, potentially increasing cure rates and reducing treatment complications.

While Cu-SAR-bisPSMA remains an unregistered product pending regulatory approval, the completion of this trial recruitment marks a significant advancement in Clarity’s clinical development program. The results, expected in the coming months, will be closely watched by the medical community and investors alike, as they could redefine standards in prostate cancer imaging.