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A Phase 2 Trial of 61Cu-NU101 PET/CT Compared Against Current Standard-of-care 18F-piflufolastat (Pylarify®) PET/CT.
Sponsor: Hoag Memorial Hospital Presbyterian
Summary
The purpose of this research is to test whether a new investigational Molecular Imaging (MI) agent called 61Cu-NU101 is equal to or better than a currently used MI agent, Pylarify, for the detection of prostate cancer metastases. 34 participants with biopsy-proven prostate cancer and cancer seen on a Pylarify PET scan will be enrolled in this study. The investigational 61Cu-NU101 PET/CT will be perfromed. If there is a difference between the standard Pylarify exam and the investigational 61Cu-NU101 exam, a biopsy of one lesion that is different between the two exams may be performed.
Official title: A Two Center Phase 2 Trial of 61Cu-noDAGa-PSMA I&T (61Cu-NU101) for Patients With Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2026-08-01
Completion Date
2028-10-01
Last Updated
2026-06-09
Healthy Volunteers
No
Conditions
Interventions
Cu-NU101
Subjects will receive a single dose of 61Cu-NU101, administered as a slow intravenous bolus over 10 seconds, with a dosage of 148 MBq (4 mCi) +/-10% , followed by PET/CT imaging 1 hour (+/- 10 minutes) and 4 hours (+/- 30 minutes) post radiotracer administration. There are no specific restrictions that should apply when administering 61Cu-NU101. There will be optional 5-minute dynamic scans at tracer administration and 20- and 40-minutes post injection.
Locations (2)
Hoag Family Cancer Institute
Newport Beach, California, United States
Washington Univeristy School of Medicine
St Louis, Missouri, United States