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

August 22, 2023 updated by: Curium US LLC

A Multi-Center, Open-Label, Randomized Phase 2 Study of Copper Cu 64 PSMA I&T Injection in Patients With Histologically Proven Metastatic Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will include a group of 26 patients with metastatic prostate cancer. Each patient will be administered a 7-9 mCi intravenous dose of copper Cu 64 PSMA I&T injection. PET/CT images will be acquired for all patients at 1 hour ± 15 minutes and 4 hours ± 30 minutes post copper Cu 64 PSMA I&T injection.

The PET/CT images will be interpreted independently by three readers blinded to all patient information. Each patient study will be assessed and scored for the detection of prostate cancer. Specifically, each reader will categorize images as "Disease" or "No Disease" based only on tumor uptake of copper Cu 64 PSMA-I&T in each of the four regions: 1) prostate bed or prostate gland, 2) lymph nodes (pelvic and extra pelvic), 3) bone, and 4) viscera/soft tissue. Analysis of the reads will be used for determination of the CLR and CDR for 1 hour and 4-hour post-injection imaging of copper Cu 64 PSMA I&T PET/CT by comparison to the Composite Reference Standard.

Study Type

Interventional

Enrollment (Actual)

29

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 Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
    • Illinois
      • Hines, Illinois, United States, 60141
        • Edward Hines, Jr. VA Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
        • Contact:
      • Saint Louis, Missouri, United States, 63104
      • Saint Louis, Missouri, United States, 63106
        • John J. Cochran Veterans Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68130
      • Omaha, Nebraska, United States, 68130
        • XCancer Omaha/Urology Cancer Center
    • Texas

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with histologically proven prostate adenocarcinoma.
  2. Prior radical prostatectomy or radiation therapy with curative intent.

  3. Recurrence of disease defined as:

    1. Prior Radical Prostatectomy: PSA > 0.2 ng/mL, or
    2. Prior Radiation Therapy: 2 ng/mL rise in PSA over post-treatment nadir
  4. Patients with at least one extraprostatic site of disease suspected based on prior imaging or diagnosed by biopsy.
  5. Age greater than or equal to 18 years.
  6. Able to understand and provide signed written informed consent.

Exclusion Criteria:

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

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: Diagnostic Imaging with 64Cu-PSMA-I&T
64Cu-PSMA I&T
Drug: 64Cu-PSMA I&T
Radiolabeled Receptor-Targeted Diagnostic Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Region-Level Correct Localization Rate (CLR)
Time Frame: 4 Hours
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)
Time Frame: 4 Hours
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
Time Frame: 24 Hours
Adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
24 Hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of Image Quality
Time Frame: 4 Hours
To compare the diagnostic quality of PET/CT images obtained at 1 hour and 4 hours post copper Cu 64 PSMA I&T injection. Image quality score is based on a scale of 0-2 where 0 is not of diagnostic quality and 2 is of best diagnostic quality.
4 Hours

Collaborators and Investigators

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

Sponsor

Curium US LLC

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 (Actual)

December 5, 2022

Primary Completion (Actual)

May 17, 2023

Study Completion (Actual)

May 17, 2023

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

December 7, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CURCu64PSM0001 (Phase II)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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