RECRUITING

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

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Conditions

Prostate CancerProstate AdenocarcinomaPSMAInitial StagingSolar-StageCu-64 PSMAPETSolar

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 3, Multi-Center, Open-label Study to Test the Diagnostic Performance of Copper Cu 64 PSMA I&T PET/CT in Staging Men With Newly Diagnosed Unfavorable Intermediate-risk, High-risk or Very High-risk Prostate Cancer Electing to Undergo Radical Prostatectomy With Pelvic Lymph Node Dissection

Quick Facts

Study Start:2024-04-01
Study Completion:2025-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06235151

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with histologically proven prostate adenocarcinoma.
  2. * Planned prostatectomy with pelvic lymph node dissection.
  3. * Unfavorable intermediate-risk, high-risk, or very high-risk disease defined by NCCN Guidelines Version 1.2023 and previous versions.
  4. * Male aged greater than or equal to 18 years.
  5. * Able to understand and provide signed written informed consent.
  1. * Androgen deprivation therapy, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or any investigational therapy against Prostate Cancer (PC) prior to prostatectomy.
  2. * Patients participating in an interventional clinical trial within 30 days and having received an Investigational Product (IP) within five (5) biological half-lives prior to administration.
  3. * Patients with any medical condition or circumstance (including receiving an IP or not capable of having a PET study) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
  4. * Patients who are planned to have an x-ray contrast within 24 hours or other PET radiotracer within 10 physical half-lives prior to the PET scan. If Barium contrast is administered this should be cleared before the PET scan.
  5. * Patients who are administered any high energy (greater than 300 KeV) gamma emitting radioisotopes within five (5) physical half-lives prior to copper Cu 64 PSMA I\&T administration.
  6. * Patients with known hypersensitivity to the active substance or any of the excipients of the IP.
  7. * Patients who had a PSMA PET scan as part of their standard medical care within 90 days prior to enrollment.

Contacts and Locations

Study Contact

Darcy Denner, PhD
CONTACT
314.600.4844
SOLAR@curiumpharma.com

Study Locations (Sites)

Arkansas Urology
Little Rock, Arkansas, 72211
United States
Providence Medical Foundation
Fullerton, California, 92835
United States
Tower Urology
Los Angeles, California, 90048
United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073
United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
United States
University of California, Irvine
Orange, California, 92868
United States
San Francisco VA Medical Center
San Francisco, California, 94121
United States
Providence Saint John's Health Center
Santa Monica, California, 90404
United States
Stanford Hospital & Clinics
Stanford, California, 94305
United States
Georgetown University Medical Center
Washington, District of Columbia, 20007
United States
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
CIRA Health
Miami, Florida, 33165
United States
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
United States
Florida Urology Partners
Tampa, Florida, 33615
United States
Edward Hines Jr. VA Hospital
Hines, Illinois, 60141
United States
Urology of Indiana, LLC
Carmel, Indiana, 46032
United States
IU Health Neuroscience Center
Indianapolis, Indiana, 46202
United States
University of Iowa
Iowa City, Iowa, 52242
United States
The University of Kansas Hospital
Kansas City, Kansas, 66160
United States
VA Boston Healthcare System
Boston, Massachusetts, 02130
United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
United States
SSM Health Saint Louis University Hospital
Saint Louis, Missouri, 63104
United States
John Cochran VA Medical Center
Saint Louis, Missouri, 63106
United States
Great Plains Health, Diagnostic Imaging
North Platte, Nebraska, 69101
United States
XCancer
Omaha, Nebraska, 68130
United States
Adaptive Research Inc.
Hawthorne, New York, 10532
United States
Queens Hospital Center
Jamaica, New York, 11432
United States
Columbia University Medical Center
New York, New York, 10032
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
VA Portland Health Care System
Portland, Oregon, 97239
United States
Carolina Urologic Research Center, LLC
Myrtle Beach, South Carolina, 29572
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Excel Diagnostics and Nuclear Oncology Center
Houston, Texas, 77042
United States
Urology San Antonio
San Antonio, Texas, 78229
United States
The Urology Place
San Antonio, Texas, 78240
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2024-04-01
Study Completion Date2025-07

Study Record Updates

Study Start Date2024-04-01
Study Completion Date2025-07

Terms related to this study

Keywords Provided by Researchers

  • PSMA
  • Prostate Cancer
  • Initial Staging
  • Solar-Stage
  • Cu-64 PSMA
  • PET
  • Solar

Additional Relevant MeSH Terms

  • Prostate Cancer
  • Prostate Adenocarcinoma