New Prostate Cancer Imaging Agent Tested in Phase 2 Trial
The study evaluates a diagnostic PET agent in patients with metastatic prostate cancer.
Updated on Oct. 6, 2026 in Cancer
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NUCLIDIUM has begun a Phase 2 trial of 61Cu-NU101, an investigational PET imaging agent designed to detect metastatic prostate cancer. The study will enroll approximately 34 patients across the United States to assess the agent's performance in locating cancer lesions.
Why it matters
Improving imaging sensitivity helps clinicians more accurately map the spread of prostate cancer, which is critical for staging and personalizing treatment decisions. This study follows preliminary data suggesting the agent may detect lesions missed by current standard methods.
This Phase 2 trial builds on Phase 1 data where 61Cu-NU101 detected additional lesions in 50% of patients compared to sensitive agents. The study now assesses this performance in 34 patients, though these results remain preliminary.
The players
NUCLIDIUM
A radiopharmaceutical company focused on developing theranostic programs for oncology.
The details
The imaging agent 61Cu-NU101 works by binding to the Prostate-Specific Membrane Antigen, a protein often overexpressed on the surface of prostate cancer cells. In the trial, patients receive a single intravenous dose, and PET/CT imaging is conducted at 1 and 4 hours post-injection. The agent is designed for efficient production, requiring only 5 minutes at room temperature for manufacture.
Timeline
2025: Phase 1 data were presented at the SNMMI Annual Meeting.
October 6, 2026: The first patient was imaged in the Phase 2 trial.
Health Landscape
The study sits within the broader evolution of PSMA-targeted imaging, which has become a cornerstone for staging prostate cancer. It specifically attempts to improve upon current radiotracer benchmarks through a theranostic framework.
While this trial represents a new diagnostic approach, it is currently limited to a small group of study participants. Patients interested in how advanced imaging might impact their own prostate cancer staging should discuss available diagnostic options with their physician.
The takeaway
This study evaluates a potential improvement in how clinicians visualize metastatic prostate cancer. Readers should continue to follow their doctor's guidance regarding standard-of-care imaging for prostate cancer diagnosis and monitoring.
Further reading
For more information on the latest research and diagnostic tools, see our Cancer section.
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