• Clarity has commenced its second registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, AMPLIFY
• AMPLIFY is a non-randomised, single-arm, open-label, multi-centre, diagnostic clinical trial to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer
• The trial aims to enroll approximately 220 participants at multiple clinical sites across the US and Australia

Clarity Pharmaceuticals (ASX: CU6) has commenced its second registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, AMPLIFY (NCT06970847). AMPLIFY is a non-randomised, single-arm, open-label, multi-centre, diagnostic clinical trial to investigate the ability of 64Cu-SAR-bisPSMA positron emission tomography (PET) to detect recurrence of prostate cancer in participants with rising or detectable prostate-specific antigen (PSA) after initial definitive treatment. The trial aims to enroll approximately 220 participants at multiple clinical sites across the United States (US) and Australia, with the first participant expected to be imaged in the coming weeks. The final study results are intended to provide sufficient evidence to support an application to the US Food and Drug Administration (FDA) for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in biochemical recurrence (BCR) of prostate cancer. The AMPLIFY trial is based on favourable preclinical and clinical data, including the Phase I/II COBRA trial in patients with BCR of prostate cancer and the Phase I PROPELLER trial in patients with confirmed prostate cancer pre-prostatectomy, which demonstrated an excellent safety profile and exciting efficacy results, especially in comparison to current standard of care imaging.

Clarity believes 64Cu-SAR-bisPSMA could become a best-in-class product and looks forward to progressing its clinical development through several trials in prostate cancer, including AMPLIFY in BCR, the first Phase III CLARIFY study in pre-prostatectomy patients, the investigator-initiated Co-PSMA trial, and the theranostic SECuRE study in metastatic castration-resistant prostate cancer.