Phase 3 Trial for Prostate Cancer Doses First Patient

The first patient has been dosed to begin the phase 3 CLARIFY trial, testing the diagnostic performance of the Cu-SAR-bisPSMAfor patients with prostate cancer before receiving a prostatectomy, according to Clarity Pharmaceuticals, the manufacturer of the product.

The goal of the CLARIFY trial is to find regional nodal metastases in patients with prostate cancer who have not yet undergone a radical prostatectomy (surgery to remove the entire prostate and surrounding lymph nodes). Researchers on the trial plan on enrolling 383 patients throughout the United States and Australia.

The first patients who has begun evaluation is following a timepoint protocol, while participating in day 1 (the day of becoming administrated) and day 2 (24 hours post- administration).

Researchers are hoping that the final results of the study will lead to an FDA approval of Cu-SAR-bisPSMAas a diagnostic agent for patients with prostate cancer before they undergo a prostatectomy.

"We are excited to have successfully dosed the first participant in the CLARIFY trial with our optimized SAR-bisPSMA agent. The trial is driven by the compelling findings from our PROPELLER trial, which highlighted the robust safety profile and superior performance of 64Cu-SAR-bisPSMA compared to standard of care imaging (68Ga-PSMA-11) with imaging on the day of administration, with two to three times the amount of product taken up in the lesions,” stated Dr. Alan Taylor, Clarity’s executive chairperson, in the release.

“The longer half-life of copper-64 based diagnostics, in comparison to the currently used gallium-68 and fluorine-18 based products, also allows for delayed imaging. These unique features have the potential to enable detection of additional lesions compared to standard of care imaging and may address the significant shortfall in sensitivity of these agents. Additionally, the extended shelf-life of 64Cu-SAR-bisPSMA of up to 48 hours, in contrast to the short shelf-life of currently available PSMA PET tracers, not only enhances scheduling flexibility for clinics, but also addresses a critical need for diagnostics in geographic areas with limited access to the current generation of radiopharmaceuticals.”

The safety, tolerability and consistency of Cu-SAR-bisPSMA PET will be evaluated within he CLARIFY trial, with an ongoing dose of 200MBq and a two-day starting timepoint.

"Clarity is steadfast in addressing the high unmet need for diagnostics and therapies in the prostate cancer domain. Our optimism is rooted in the belief that our SAR-bisPSMA product can redefine diagnostic standards and improve patient outcomes. As we progress with the CLARIFY trial, we anticipate validating and building upon the positive data accumulated so far. Our vision is a future where enhanced diagnostic tools empower clinicians to make more informed decisions, ultimately shaping the optimal course of treatment for their patients.

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