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

ConditionProstate Cancer

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Cu-NU101
Drug
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.

Treatment groups

34 Participants

are divided into 1 treatment group

Group A: Cu-NU101Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Sensitivity of imaging with 61Cu- NU101,

Demonstrate the sensitivity of imaging with 61Cu- NU101, as compared to a currently standard of care PSMA-targeted imaging agent, 18F-piflufolastat.

Time frame

4 hours post-administration

Secondary outcomes

Assessing the sensitivity of the 61Cu-NU101 scan

Sensitivity will be determined by comparing the lesions identified with 61Cu-NU101 against those identified with standard-of-care 18F-piflufolastat, with histology as the reference standard.

Time frame

1 hour post-administration

Sponsors and contacts

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Hoag Memorial Hospital Presbyterian

Lead sponsor

Washington University School of Medicine

Collaborator

Nuclidium