Clarity Pharmaceuticals Doses First Two Participants in Diagnostic Trial for Prostate Cancer Recurrence

Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company, has announced that the first two participants in its new investigator-initiated trial, Co-PSMA, have been dosed with its proprietary product, ⁶⁴Cu-SAR-bisPSMA. The trial is comparing the diagnostic performance of the company’s product against the standard of care (SOC), ⁶⁸Ga-PSMA-11, in detecting prostate cancer recurrence.

The trial, led by Louise Emmett, MBChB, MD, of St. Vincent’s Hospital in Sydney, Australia, is evaluating 50 patients with biochemical recurrence (BCR) after radical prostatectomy “who are being considered for curative salvage radiotherapy.” The primary objective of the study is to compare rates of detection of prostate cancer sites by measuring the number of each participant’s lesions with both diagnostic methods.

According to a news release published by Clarity Pharmaceuticals, both the PROPELLER and COBRA trials have also previously evaluated the diagnostic abilities of ⁶⁴Cu-SAR-bisPSMA versus SOC. In the PROPELLER trial, ⁶⁴Cu-SAR-bisPSMA showed superior same-day imaging and detected more prostate cancer lesions than the SOC, and in the COBRA trial, 82% more prostate cancer lesions were identified by ⁶⁴Cu-SAR-bisPSMA using next-day imaging.

“Patients have already been dosed and had same-day and next-day imaging within a few days after Co-PSMA initiation,” Alan Taylor, PhD, executive chairperson of Clarity Pharmaceuticals, explained. “This indicates that there is a high unmet need for improved prostate cancer diagnostics in this patient population, which is the largest population for PSMA imaging globally.”

Moreover, Dr. Taylor emphasized that the diagnostic abilities of ⁶⁴Cu-SAR-bisPSMA, compared with those of the SOC have already been demonstrated in both the PROPELLER and COBRA trials. In addition, Clarity Pharmaceuticals is continuing to explore the results of both PROPELLER and COBRA, as well as Co-PSMA, in their phase III clinical trials, CLARIFY and AMPLIFY, which are taking place in the US and Australia.

“As the diagnostic performance of ⁶⁴Cu-SAR-bisPSMA has been demonstrated through previous clinical trials, such as COBRA and PROPELLER, we eagerly await the results of this head-to-head comparison between ⁶⁴Cu-SAR-bisPSMA and ⁶⁸Ga-PSMA-11 PET in the hope of opening the opportunity for earlier detection of disease as we progress towards our ultimate goal of better treating people with cancer,” Dr. Taylor said.