NUCLIDIUM Images First Patient in Phase 2 Copper-61 Prostate Cancer Study
Published in Diseases!, Drugs development & discovery, Scanners and Imaging.
Publication date: October 9, 2026. Source announcement: October 6, 2026.
NUCLIDIUM has announced that the first patient was imaged in a Phase 2 study of its investigational copper-61 PET radiotracer, 61Cu-NU101, for metastatic prostate cancer. The milestone marks clinical progress in evaluating the diagnostic agent; it is not a report of Phase 2 results.
The tracer couples copper-61 with a peptide targeting prostate-specific membrane antigen (PSMA). The investigator-initiated, non-randomized study plans to enroll approximately 34 patients with biopsy-confirmed metastatic prostate cancer at U.S. clinical sites.
Participants will receive one intravenous dose, followed by PET/CT scans one and four hours later. The primary endpoint compares lesion-detection sensitivity with an FDA-approved fluorine-18 PSMA tracer, using pathology as the reference standard. Secondary assessments include comparisons with CT and bone scans, alongside safety.
NU101 also includes a copper-67 therapeutic candidate within the company’s theranostic development program. Diagnostic imaging progress does not establish the therapeutic candidate’s efficacy, prove superiority over approved tracers, or confer marketing approval. The planned comparison should provide more informative evidence than this first-patient milestone.