Clarity Pharmaceuticals has announced plans to begin a pivotal Phase III study of its ⁶⁴Cu SAR-bisPSMA diagnostic in prostate cancer (PC), after completing an end-of-phase meeting with the US Food and Drug Administration (FDA).

The CLARIFY study is anticipated to commence enrolment of patients at the end of this year and the FDA is supporting this clinical trial of ⁶⁴Cu SAR-bisPSMA PET in 383 subjects with untreated, histopathology-confirmed PC.

This Phase III trial will evaluate ⁶⁴Cu SAR-bisPSMA PET’s diagnostic performance for detecting PC within the pelvic lymph nodes.

Assessment will be carried out across two imaging time points: on day one (day of administration) and day two (24 hours post-administration).

The trial’s objective is to generate sufficient evidence to support an application for FDA approval of ⁶⁴Cu SAR-bisPSMA as a new diagnostic imaging agent in PC.

Clarity Pharmaceuticals executive chairperson Dr Alan Taylor said: “The positive results from our completed PROPELLER trial showed that ⁶⁴Cu SAR-bisPSMA is safe and its uptake in PSMA-expressing cancer lesions was significantly higher compared to the approved standard-of-care PSMA imaging agent for PC in Australia and the US.

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“This may enable diagnosis of additional and smaller lesions, especially when coupled with the opportunity for delayed imaging, a characteristic not available to the first generation of PSMA imaging agents that exhibit high specificity but low sensitivity in diagnosing metastases outside of the prostate.”