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Brief Title: Imaging Study to Investigate Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Suspected Prostate Cancer Recurrence (SPOTLIGHT)
Official Title: A Prospective, Phase 3, Multi Center, Single-arm, Imaging Study Investigating the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) PET Ligand in Men With Suspected Prostate Cancer Recurrence Based on Elevated PSA Following Prior Therapy.
Study ID: NCT04186845
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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, Saint Louis, Missouri, United States
Montefiore Hospital, Bronx, 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
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
Turku University Hospital, Turku, , Finland
CWZ, Nijmegen, , Netherlands
Maxima MC, Veldhoven, , Netherlands