Swiss radiopharmaceutical company Nuclidium has imaged the first patient in a phase II trial evaluating the diagnostic accuracy and safety of its copper-61 (Cu-61)-NU101 PET agent in patients with metastatic prostate cancer.
Cu-61-NU101 targets the prostate-specific membrane antigen (PSMA) and serves as the diagnostic component of the company's NU101 theranostic program, which pairs it with the copper-67 (Cu-67)-NU101 therapeutic. The tracer can be produced in five minutes at room temperature, enabling on-demand preparation in hospitals, according to the firm.
The investigator-initiated, nonrandomized trial will enroll about 34 patients with biopsy-confirmed metastatic prostate cancer at U.S. sites, with PET/CT imaging performed at one and four hours after injection. The primary endpoint compares the sensitivity of lesion detection with Cu-61-NU101 against a fluorine-18 (F-18)-based PSMA tracer approved by the U.S. Food and Drug Administration (FDA), with pathology as the reference standard, Nuclidium said.
