Imaging Study to Investigate Safety and Diagnostic Performance of 18F rhPSMA 7.3 PET Ligand in Suspected Prostate Cancer Recurrence

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 rhPSMA 7.3 (18F) Positron Emission Tomography (PET) ligand in men with suspected prostate cancer recurrence based on elevated Prostate-specific antigen (PSA) following prior therapy.

Key facts

Study ID

NCT04186845

Run by

Blue Earth Diagnostics

People needed

391

Starts

2020-05-04

Expected to finish

2021-04-28

Last updated by the study team

2025-09-22

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.
• History of localized adenocarcinoma of the prostate with prior curative intent treatment.
• An elevated PSA, clinically suspicious for biochemically recurrent disease:
• Following Radical Prostatectomy: PSA >0.2 ng/mL
• Following Radiotherapy: nadir +2 ng/mL.
• Potentially eligible for salvage therapy with curative intent.

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 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
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University — Baltimore, Maryland, United States
• Chesapeake Urology Research Associates — Towson, Maryland, 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
• 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
• MD Anderson Hospital — Houston, Texas, United States
• Urology San Antonio — San Antonio, Texas, United States
• University of Virginia - Health Science Center — Charlottesville, Virginia, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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