Phase 2 61Cu-NU101 PSMA-targeted PET radiotracer (PSMA ligand) vs Pylarify in prostate cancer

This Phase 2, two-center, single-arm diagnostic comparison study tests whether the investigational PET radiotracer 61Cu-noDAGa-PSMA I&T (61Cu-NU101) can match or outperform the current standard 18F-piflufolastat (Pylarify) for detecting metastatic prostate cancer. Participants must have biopsy-proven prostate cancer with at least one lesion already seen on a prior Pylarify PET/CT, creating a “head-to-head within the same patient” imaging comparison. The intervention is a single IV bolus of 61Cu-NU101 (148 MBq / 4 mCi ±10%) followed by PET/CT at ~1 hour and ~4 hours post-injection (optional dynamic imaging around injection). Mechanistically, 61Cu-NU101 is a PSMA-binding small-molecule radiotracer, aiming to leverage copper-61 imaging kinetics to potentially enable higher-contrast or delayed-timepoint lesion detection than 18F agents. Clinically, men with oligometastatic/PSMA-avid disease are typically worked up and managed with PSMA PET–guided staging plus metastasis-directed RT and systemic therapy (and, when appropriate, prostate-directed local therapy), and this trial probes whether a new PSMA PET tracer could refine where disease truly is before treatment decisions. Hoag Memorial Hospital Presbyterian sponsors the study; the NU101 program is associated with Nuclidium’s copper-based PSMA portfolio in the broader field.