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

June 3, 2026 updated by: Gary Ulaner, Hoag Memorial Hospital Presbyterian

A Two Center Phase 2 Trial of 61Cu-noDAGa-PSMA I&T (61Cu-NU101) for Patients With Prostate Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 61Cu-NU101 PET/CT, as follows: Each subject will receive a single administration of 61Cu-NU101, followed by PET/CT imaging at 1 and 4 hours. There will be optional 5-minute dynamic scans at tracer administration and 20- and 40-minutes post injection. Safety of 61Cu-NU101 will be evaluated by monitoring for unlikely adverse events. Ability of 61Cu-NU101to visualize malignant lesions will be evaluated by comparing the number of suspicious lesions demonstrated on the standard-of-care 18F-piflufolastat PET/CT with the number of suspicious lesions demonstrated on the experimental 61Cu-NU101PET/CT. Positive lesions will be considered to be foci greater than local background that are not physiologic/benign by location. If there is a discrepancy between the number of lesions detected by 18F-piflufolastat PET/CT and 61Cu-NU101PET/CT, then a discrepant lesion will be selected for biopsy to provide pathologic proof as a reference standard, if possible.

Determination of lesions suspicious for malignancy on 18F-piflufolastat PET/CT and 61Cu-NU101: The previously performed standard-of-care 18F-piflufolastat PET/CT and the on-trial research 61Cu-NU101will be evaluated using the same methodology, by radiologists with expertise in the interpretation of PSMA-targeted PET/CT imaging. Abnormal tracer accumulation will be defined as areas of uptake outside of sites considered physiologic or inflammatory. The locations of focal tracer abnormalities will be recorded. Radiotracer uptake will be graded on a scale of 1-5 where 1 = definitely normal, 2 = probably normal, 3 = equivocal, 4 = probably abnormal, and 5 = definitely abnormal. Semiquantitative analysis of tracer uptake will be performed for grade 4 and 5 lesions. Three-dimensional regions of interest (ROIs) will be placed in areas of tracer uptake and used for quantification of standardized uptake value (SUV), calculated as: SUV = decay-corrected mean ROI activity (μCi/ml) / (injected dose (μCi)/ body weight (g)). SUVmax will be recorded. Lesions graded as 4 (probably abnormal) or 5 (definitely abnormal) for malignancy will be counted and included in the number on lesions suspicious for malignancy in each examination.

Determination of lesions suspicious for malignancy on CT and bone scan: As a secondary objective, the number of lesions suspicious for malignancy will be compared between 61Cu-NU101and standard-of-care CT/bone scan. CT and bone scan will be interpreted by radiologists with expertise in the interpretation in CT and bone scans. Abnormal findings on CT and bone scan will be graded on a scale of 1-5 where 1 = definitely normal, 2 = probably normal, 3 = equivocal, 4 = probably abnormal, and 5 = definitely abnormal. No quantitative measurements will be made on CT and bone scan. For osseous lesions, a corresponding lesion on CT and bone scan will be counted as only 1 lesion. Lesions graded as 4 (probably abnormal) or 5 (definitely abnormal) for malignancy will be counted and included in the number on lesions suspicious for malignancy.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Hoag Family Cancer Institute
        • Principal Investigator:
          • Gary Ulaner, MD, PhD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington Univeristy School of Medicine
        • Contact:
          • Vikas Prasad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cu-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.
Drug: Cu-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of imaging with 61Cu- NU101,
Time Frame: 4 hours post-administration
Demonstrate the sensitivity of imaging with 61Cu- NU101, as compared to a currently standard of care PSMA-targeted imaging agent, 18F-piflufolastat.
4 hours post-administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing the sensitivity of the 61Cu-NU101 scan
Time Frame: 1 hour post-administration
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.
1 hour post-administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoag Memorial Hospital Presbyterian

Collaborators

Washington University School of Medicine
Nuclidium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 149-25-CA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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