Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

A prospective, Phase 3, multi center, single-arm, imaging study investigating the safety and diagnostic performance of Radio-hybrid Prostate Specific Membrane Antigen (rhPSMA) 7.3 (18F) Positron Emission Tomography (PET) ligand in men with newly diagnosed prostate cancer.

Key facts

Study ID

NCT04186819

Run by

Blue Earth Diagnostics

People needed

356

Starts

2020-03-02

Expected to finish

2021-06-21

Last updated by the study team

2025-02-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patient is male and aged >18 years old.
• Histologically confirmed adenocarcinoma of the prostate.
• Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).

You may not qualify if…

• Patients who are planned to have an x-ray contrast agent or other PET radiotracer <24 hours prior to the PET scan.
• Patients currently receiving, or with a prior history of, Androgen Deprivation Therapy (ADT).

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Tower Urology — Los Angeles, California, United States
• University of California Irvine Medical Center (UCIMC) — Orange, California, United States
• John Wayne Cancer Institute — Santa Monica, California, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northside Hospital — Austell, Georgia, United States
• NorthShore University HealthSystem — Evanston, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Richard L Roudebush VA Medical Center — Indianapolis, Indiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Chesapeake Urology Research Associates — Towson, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Michigan, Ann Arbor — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• The Urologic Institute of Northeastern New York - Community — Albany, New York, United States
• Queens Hospital Center (QHC) - Queens Cancer Center — Jamaica, New York, United States
• Mount Sinai Faculty Practice Associates — New York, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• Montefiore Hospital — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• MidLantic Urology — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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