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ACTIVE NOT RECRUITING
NCT03976843
PHASE2

Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

Background: People with prostate cancer usually have their cancer imaged with a CT scan and bone scan. They then have their prostate gland removed. Researchers want to test a scan that might predict if prostate cancer will return after this surgery. Objective: To test if a PET/CT scan before the prostate gland is removed can predict if prostate cancer will return. Also, to test if this approach is better or worse than the usual approach for prostate cancer. Eligibility: Men ages 18 and older with prostate cancer that appears to be contained within the prostate but is at risk of having spread Design: Participants will be screened with: * Medical history * Blood tests * CT and MRI scans: Participants will lie in a machine. The machine will take pictures of the body. * Bone scan Participants will have a radiotracer injected into a vein. They will have a PET/CT scan of their whole body 60-90 minutes later. During the scan, they will lie on their back and stay still. Within 60 days after the scan, participants will have surgery. This will remove the prostate gland and lymph nodes around it. Some tissue will be used for genetic testing. If the PET/CT scan suggests the cancer has spread, participants may need to have another biopsy within 60 days after the scan. After surgery, participants will have follow-up visits for 5 years. They will have 5 visits the first year and 2 the second. Then they will have visits once a year. If participants cancer returns, they will have repeat PET/CT scans.

Official title: A Phase II Multi-Institutional Trial to Evaluate Prostate Specific Membrane Antigen (PMSA)-Based PET Imaging of High Risk Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

175

Start Date

2019-12-04

Completion Date

2027-11-19

Last Updated

2026-04-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

18F-DCFPyL

18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging

Locations (6)

Tulane University

New Orleans, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Brigham and Women s Hospital

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States