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

NCT07635524 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: 149-25-CA
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate; cancer; metastatic; radiotracer; metastases

Outcome Measures

Primary Outcomes (1)

• 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.

  4 hours post-administration

Secondary Outcomes (1)

• Assessing the sensitivity of the 61Cu-NU101 scan

  1 hour post-administration

Study Arms (1)

Cu-NU101

EXPERIMENTAL

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

Interventions

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.

Cu-NU101

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must be a biological male to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoag Memorial Hospital Presbyterian: lead
• Washington University School of Medicine: collaborator
• Nuclidium: collaborator

Study Sites (2)

Hoag Family Cancer Institute

Newport Beach, California, 92663, United States

Location

Washington Univeristy School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Prostatic Neoplasms; Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Gary Ulaner, MD, PhD

CONTACT

949-557-0285; gary.ulaner@hoag.org

Beth Thomsen, CNMT

CONTACT

949-557-0285; beth.thomsen@hoag.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James & Pamela Muzzy Endowed Chair of Molecular Imaging and Therapy

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)