Cu-64-PSMA-I&T Positron Emission Tomography (PET) Imaging of Metastatic PSMA Positive Lesions in Men With Prostate Cancer

NCT05653856 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CURCu64PSM0001 (Phase II)
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 9

Brief Summary

This is a prospective, open-label Phase 2 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with recurrent metastatic prostate cancer after radical prostatectomy or radiation therapy.

Conditions

Metastasis From Malignant Tumor of Prostate (Disorder)

Keywords

PSMA; Prostate Cancer; PET; SOLAR; Cu-64 PSMA

Outcome Measures

Primary Outcomes (3)

• Region-Level Correct Localization Rate (CLR)

  To determine the region-level correct localization rate (CLR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CLR is defined as the percentage of regions containing at least one true PET positive lesion, with exactly localized correspondence between PET/CT imaging and the Composite Reference Standard regardless of any co-existent false positive findings, within the same region, out of all regions containing at least one PET positive finding.

  4 Hours

• Patient-Level Correct Detection Rate (CDR)

  To determine the patient-level correct detection rate (CDR) of copper Cu 64 PSMA I\&T injection PET/CT imaging for the detection of recurrent metastatic prostate cancer at 1 hour and 4 hours post injection. The CDR is defined as the percentage of patients who have at least one true PET positive lesion, with exactly localized correspondence between PET imaging and the Composite Reference Standard, regardless of any co-existent false positive findings, out of all patients who are scanned.

  4 Hours

• Incidence of Adverse Events

  Adverse events (AEs) were assessed from the time of copper Cu 64 PSMA I\&T injection throughout the24-hour assessment period. AEs were assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  24 Hours

Secondary Outcomes (1)

• Score of Image Quality

  4 Hours

Study Arms (1)

Diagnostic Imaging with 64Cu-PSMA-I&T

EXPERIMENTAL

64Cu-PSMA I\&T

Drug: 64Cu-PSMA I&T

Interventions

64Cu-PSMA I&T DRUG

Radiolabeled Receptor-Targeted Diagnostic Product

Diagnostic Imaging with 64Cu-PSMA-I&T

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically proven prostate adenocarcinoma.
• Prior radical prostatectomy or radiation therapy with curative intent.
• Recurrence of disease defined as:
• Prior Radical Prostatectomy: PSA \> 0.2 ng/mL, or
• Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
• Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
• Age greater than or equal to 18 years.
• Able to understand and provide signed written informed consent.

You may not qualify if:

• Androgen deprivation therapy (ADT) or other therapies targeting the androgen pathway, unless subject has a rising PSA level.
• Body weight greater than 350 lb (158 kg).
• Investigational therapy within the past 30 days.
• Creatinine clearance (ClCr) less than 30 mL/min.
• Participants who are capable of fathering a child and who are unwilling to take precautions to prevent pregnancy.

Sponsors & Collaborators

• Curium US LLC: lead

Study Sites (9)

Yale University

New Haven, Connecticut, 06520, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

John J. Cochran Veterans Hospital

St Louis, Missouri, 63106, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

XCancer Omaha/Urology Cancer Center

Omaha, Nebraska, 68130, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Darcy Denner
• Organization: Curium

Solar@curiumpharma.com

314-506-3511

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: December 16, 2022
• Study Start: December 5, 2022
• Primary Completion: May 17, 2023
• Study Completion: May 17, 2023
• Last Updated: January 24, 2025
• Results First Posted: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)