Clarity's Executive Chairman, Dr Alan Taylor, commented, "The prostate cancer market is a key focus for Clarity and we are very pleased to commence this clinical trial for men with mCRPC using our optimised theranostic PSMA products, ^64/67Cu SAR-bisPSMA. The exciting news about the commencement of the SECuRE trial (NCT04868604)^[1] comes shortly after the initiation of our diagnostic ⁶⁴Cu SAR-bisPSMA clinical trial called PROPELLER (NCT04839367)^[2]. Clarity's SAR-bisPSMA products hold great promise of improving prostate cancer diagnosis and treatment and have the potential to provide multiple benefits in comparison to current products in the market."

The SECuRE trial is a Phase I/IIa theranostic trial for identification and treatment of PSMA-expressing mCRPC using Targeted Copper Theranostics (TCT). ⁶⁴Cu SAR-bisPSMA is used for diagnosis and selection of patients and ⁶⁷Cu SAR-bisPSMA for therapy. It is a multi-centre, single arm, dose escalation study with a cohort expansion planned for up to 44 patients in the US. The aim of this study is to determine the safety and efficacy of ⁶⁷Cu-SAR-bisPSMA as a therapy.

Dr Taylor said: "We look forward to progressing both the SECuRE and PROPELLER trials in patients with prostate cancer to build on the compelling results from our therapeutic and diagnostic preclinical studies. There is a high unmet need for early detection and better treatment options for patients with prostate cancer, especially with mCRPC, for which the median life expectancy is less than three years. We believe that the TCT hold great promise for this patient population due to the logistical, manufacturing and treatment benefits associated with the optimised SAR-bisPSMA product and the "perfect pairing" of copper-64 (⁶⁴Cu) and copper-67 (⁶⁷Cu) radioisotopes. We look forward to progressing these trials and getting closer to achieving our ultimate goal of developing better treatments for children and adults with cancer."