A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer

NCT06736054 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 189-21-CA
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Molecular Imaging (MI) uses tracers which emit radiation to provide clinically valuable imaging for patient with cancer. Most current MI agents utilize Fluorine 18 or Gallium 68 as the positron emitter for PET imaging. However, these isotopes have short half-lives which limit the geographic distribution range of tracers made with these isotopes. Copper 61 (61Cu) has a 3.3 hour half-life, which would allow for far greater distribution range following radiotracer production. This phase I trial will test the safety and effectiveness of a novel MI radiotracer that uses 61Cu as its positron emitting isotope and targets Prostate Specific Membrane Antigen (PSMA) for imaging prostate cancer. A successful trial will provide the ability to advance this novel 61Cu-NODAGA-PSMA radioisotope into phase II trials, as well as open a new paradigm into the production of MI radioisotopes with 61Cu.

Conditions

Prostate Adenocarcinoma

Keywords

PSMA; PET/CT; Phase 1

Outcome Measures

Primary Outcomes (1)

• Incidence of Imaging Agent-Emergent Adverse Events [Safety and Tolerability]

  For the primary objective of safety, side effects will be monitored the day of and the day following radiotracer administration.

  Up to 24 hours after administration of radiotracer

Secondary Outcomes (2)

• Dosimetry

  Up to 24 hours after administration of radiotracer

• Number of suspected PSMA-positive malignant lesions

  Up to 24 hours after administration of radiotracer

Study Arms (1)

Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET/CT

EXPERIMENTAL

TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration.

Drug: Copper 61-PSMA PET/CT

Interventions

Copper 61-PSMA PET/CT DRUG

TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration.

Prostate Adenocarcinoma with PSMA-Positive Disease on a PSMA Targeted PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• 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 1
• At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment
• Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL/minute.

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

Study Sites (1)

Hoag Memorial Hospital Presbyterian

Irvine, California, 92616, United States

RECRUITING

Related Publications (1)

• Basaco Bernabeu T, Mansi R, Del Pozzo L, Zanger S, Gaonkar RH, McDougall L, De Rose F, Jaafar-Thiel L, Herz M, Eiber M, Ulaner GA, Weber WA, Fani M. 61Cu-PSMA-Targeted PET for Prostate Cancer: From Radiotracer Development to First-in-Human Imaging. J Nucl Med. 2024 Sep 3;65(9):1427-1434. doi: 10.2967/jnumed.123.267126.

  PMID: 39025646 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 16, 2024
• Study Start: October 14, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)