A Phase 2 Trial of 61Cu-NU101 PET/CT Compared Against Current Standard-of-care 18F-piflufolastat (Pylarify®) PET/CT.

Starting soon · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT07635524

Run by

Hoag Memorial Hospital Presbyterian

People needed

34

Starts

2026-08-01

Expected to finish

2028-10-01

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Biopsy proven prostate adenocarcinoma
• Age ≥ 18 years
• ECOG 0 or 2 4 .Oligometastatic disease (1-5 radiotracer avid disease sites) on 18F- piflufolastat PET/CT within 30 days of trial recruitment

You may not qualify if…

• Known allergy/hypersensitivity to PSMA-targeted imaging agents
• Other active malignancy, other than the known prostate cancer

Where it is running

• Hoag Family Cancer Institute — Newport Beach, California, United States
• Washington Univeristy School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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