A Two Center Phase 2 Trial of 61Cu-noDAGa-PSMA I&T (61Cu-NU101) for Patients With Prostate Cancer
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.
Description
This is an open, phase 2, two center, non-randomized trial. Total of 34 subjects are planned, based on a statistical analysis to provide 80% power to determine non-inferiority of 61Cu-NU101 as compared to 18F-piflufolastat PET/CT. Each participant will have biopsy-proven prostate cancer visualized on standard-of-care 18F-piflufolastat PET/CT performed within 30 days of trial accrual. If participants have not had a diagnostic quality CT and/or a bone scan within 30 days of trial accrual, then will undergo a diagnostic quality CT and/or bone scan, as needed. Participants will undergo a research…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Biopsy proven prostate adenocarcinoma 2. Age ≥ 18 years 3. ECOG 0 or 2 4 .Oligometastatic disease (1-5 radiotracer avid disease sites) on 18F- piflufolastat PET/CT within 30 days of trial recruitment Exclusion Criteria: 1. Known allergy/hypersensitivity to PSMA-targeted imaging agents 2. Other active malignancy, other than the known prostate cancer
Interventions
- DrugCu-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 InstituteNewport Beach, California
- Washington Univeristy School of MedicineSt Louis, Missouri