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

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ClinicalTrials.gov Identifier: NCT05653856
Recruitment Status : Recruiting
First Posted : December 16, 2022
Last Update Posted : March 22, 2023
Sponsor:
Information provided by (Responsible Party):
Curium US LLC

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastasis From Malignant Tumor of Prostate (Disorder) Drug: 64Cu-PSMA I&T Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : December 5, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05653856


Contacts
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Contact: Darcy Denner 314-506-3511 Solar@curiumpharma.com

Locations
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United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520
Contact: Kristin DeFrancesco       kristin.defrancesco@yale.edu   
United States, Illinois
Edward Hines, Jr. VA Hospital Recruiting
Hines, Illinois, United States, 60141
Contact: Joseph Ringelstein       joseph.ringelstein@va.gov   
United States, Maryland
Johns Hopkins University Terminated
Baltimore, Maryland, United States, 21287
United States, Missouri
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63104
Contact: Martha Edwards    314-977-4498    martha.edwards.1@health.slu.edu   
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jennifer Frye    314-747-1604    Fryej@wustl.edu   
United States, Nebraska
Nebraska Cancer Specialists Recruiting
Omaha, Nebraska, United States, 68130
Contact: Marlene Bridwell       mbridwell@nebraskacancer.com   
XCancer Omaha/Urology Cancer Center Recruiting
Omaha, Nebraska, United States, 68130
Contact: Tony Romero       tromero@gucancer.com   
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Kayode Ahmed       KMAhmed@mdanderson.org   
Sponsors and Collaborators
Curium US LLC
More Information
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Responsible Party: Curium US LLC
ClinicalTrials.gov Identifier: NCT05653856    
Other Study ID Numbers: CURCu64PSM0001 (Phase II)
First Posted: December 16, 2022    Key Record Dates
Last Update Posted: March 22, 2023
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Curium US LLC:
PSMA
Prostate Cancer
PET
SOLAR
Cu-64 PSMA
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases