XCancer

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

Description:

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

Government Study Link:

NCT07635524 - Click here to see study on

ClinicalTrials.gov

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
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