Clinical Trial · NCT07635524

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

Overview

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.

Sponsor

Hoag Memorial Hospital Presbyterian

Phase

Phase 2

Contacts

Gary Ulaner, MD, PhD (CONTACT)

gary.ulaner@hoag.org

949-557-0285

Beth Thomsen, CNMT (CONTACT)

beth.thomsen@hoag.org

949-557-0285

ClinicalTrials.gov

NCT07635524

Drug / Compound

piflufolastat

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

piflufolastat

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

NU101

Isotope(s):

Target(s):

PSMA

Ligand Class: Small Molecules

Eligibility

Inclusion

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

Exclusion

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