Copper Cu 64 PSMA I&T PET Imaging in Men With Newly Diagnosed Prostate Cancer

Part of paid clinical trials in Homewood, Alabama.

Sponsor
Curium US LLC
Study ID
NCT06235151
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Copper Cu 64 PSMA I&T — DRUG
    Radiopharmaceutical PET imaging tracer injected intravenously for staging of prostate cancer.

Study Details

This is a prospective, open-label Phase 3 study to evaluate copper Cu 64 PSMA I\&T injection for PET/CT imaging in patients with newly diagnosed unfavorable intermediate high-risk, high-risk or very high-risk prostate cancer.

Key Dates

Start date
Apr 1, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
439 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic Imaging with Copper Cu 64 PSMA I&T
    Copper Cu 64 PSMA I\&T Injection

Primary Outcome Measure

Sensitivity [ Time Frame: 4 Hours ]

Central Contacts

Locations (44)

FacilityCityStateZIPSite coordinators
Urology Centers of AlabamaHomewoodAlabama35209-
Arkansas UrologyLittle RockArkansas72211-
Providence Medical FoundationFullertonCalifornia92835-
Tower UrologyLos AngelesCalifornia90048-
VA Greater Los Angeles Healthcare SystemLos AngelesCalifornia90073-
Hoag Memorial Hospital PresbyterianNewport BeachCalifornia92663-
University of California, IrvineOrangeCalifornia92868-
San Francisco VA Medical CenterSan FranciscoCalifornia94121-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
Providence Saint John's Health CenterSanta MonicaCalifornia90404-
Stanford Hospital & ClinicsStanfordCalifornia94305-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
CIRA HealthMiamiFlorida33165-
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Sarasota Memorial Health Care SystemSarasotaFlorida34239-
Florida Urology PartnersTampaFlorida33615-
Edward Hines Jr. VA HospitalHinesIllinois60141-
Urology of Indiana, LLCCarmelIndiana46032-
IU Health Neuroscience CenterIndianapolisIndiana46202-
University of IowaIowa CityIowa52242-
The University of Kansas HospitalKansas CityKansas66160-
United TheranosticsGlen BurnieMaryland21061-
VA Boston Healthcare SystemBostonMassachusetts02130-
M Health Fairview University of Minnesota Medical CenterMinneapolisMinnesota55455-
John Cochran VA Medical CenterSt LouisMissouri63106-
SSM Health Saint Louis University HospitalSt LouisMissouri63104-
Great Plains Health, Diagnostic ImagingNorth PlatteNebraska69101-
XCancerOmahaNebraska68130-
United TheranosticsPrincetonNew Jersey08540-
Adaptive Research Inc.HawthorneNew York10532-
Queens Hospital CenterJamaicaNew York11432-
Columbia University Medical CenterNew YorkNew York10032-
James J. Peters VA Medical CenterThe BronxNew York10468-
UNC Cancer CenterChapel HillNorth Carolina27514-
Cleveland ClinicClevelandOhio44195-
Dayton Physicians Network / Greater Dayton Cancer CenterKetteringOhio45409-
VA Portland Health Care SystemPortlandOregon97239-
Hollings Cancer CenterCharlestonSouth Carolina29425-
Carolina Urologic Research Center, LLCMyrtle BeachSouth Carolina29572-
University of Tennessee Medical CenterKnoxvilleTennessee37920-
Excel Diagnostics and Nuclear Oncology CenterHoustonTexas77042-
The Urology PlaceSan AntonioTexas78240-
Urology San AntonioSan AntonioTexas78229-
Fred Hutchinson Cancer CenterSeatleWashington98109-

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