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.
For similar stories and updates, check out AuntMinnie’s Radiopharmaceutical Therapy Tracker.
