Blue Earth Diagnostics has released top-line results from its phase III trial evaluating the performance of its prostate-specific membrane antigen (PSMA) radiotracer for imaging in newly diagnosed prostate cancer.
Endpoints for the trial were patient-level sensitivity and specificity of F-18 rhPSMA-7.3-PET for the detection of pelvic lymph node metastases using histopathology as the standard of truth. In 296 patients who underwent F-18 rhPSMA-7.3-PET/CT, the overall specificity of the approach was 96% (217/226) and the overall sensitivity was 24% (17/70) by majority read, according to the company.
The results are consistent with reports to date of sensitivity within the class of PSMA-targeted diagnostic imaging radiopharmaceuticals, Blue Earth said. The findings are included in Blue Earth's New Drug Application for F-18 rhPSMA-7.3, which is currently under review by the U.S. Food and Drug Administration.