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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorHoag Memorial Hospital Presbyterian

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Known allergy/hypersensitivity to PSMA-targeted imaging agents

Other active malignancy, other than the known prostate cancer

Trial design

Treatments tested in this trial

  • Cu-NU101

Treatment groups

34 Participants
are divided into 1 treatment group

Sponsors and collaborators

Hoag Memorial Hospital Presbyterian

Lead sponsor

Washington University School of Medicine

Collaborator

Nuclidium

Collaborator