Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company, and PSI CRO, a global contract research organization, plan to conduct a trial using Clarity's phase III diagnostic trial of Clarify for prostate cancer patients.
Clarify derives from PET imaging using copper-64 (Cu-64) SAR-bisPSMA in participants with high-risk prostate cancer prior to radical prostatectomy. It is a prospective, single-arm, multicenter, blinded-review, diagnostic performance study that will include 383 participants.
The aim of the trial is to assess the diagnostic performance of Cu-64 SAR-bisPSMA PET to detect prostate cancer within lymph nodes located in the pelvic region. Evaluation will take place over two imaging time points, day one (day of administration) and day two (about 24 hours after administration). Clarity said the trial is expected to begin recruitment in late 2023.