Imaging Study to Investigate the Safety and Diagnostic Performance of rhPSMA 7.3 (18F) in Newly Diagnosed Prostate Cancer.
NCT ID: NCT04186819
Last Updated: 2025-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
356 participants
INTERVENTIONAL
2020-03-02
2021-06-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Patients
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
rhPSMA-7.3 (18F) Injection
Radioligand for PET CT scanning
Positron Emission Tomography scan
imaging test with radioligand
Interventions
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rhPSMA-7.3 (18F) Injection
Radioligand for PET CT scanning
Positron Emission Tomography scan
imaging test with radioligand
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed adenocarcinoma of the prostate.
3. Patients electing to undergo Radical Prostatectomy (RP) with Pelvic lymph node dissection (PLND).
Exclusion Criteria
2. Patients currently receiving, or with a prior history of, Androgen Deprivation Therapy (ADT).
18 Years
MALE
No
Sponsors
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Parexel
INDUSTRY
Blue Earth Diagnostics
INDUSTRY
Responsible Party
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Locations
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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
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 PC
Norfolk, Virginia, United States
Turku University Hospital
Turku, , Finland
Klinik und Poliklinik fur Urologie
Hamburg, , Germany
TU München
Munich, , Germany
CWZ
Nijmegen, , Netherlands
Maxima MC
Veldhoven, , Netherlands
Countries
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References
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Surasi DS, Eiber M, Maurer T, Preston MA, Helfand BT, Josephson D, Tewari AK, Somford DM, Rais-Bahrami S, Koontz BF, Bostrom PJ, Chau A, Davis P, Schuster DM, Chapin BF; LIGHTHOUSE Study Group. Diagnostic Performance and Safety of Positron Emission Tomography with 18F-rhPSMA-7.3 in Patients with Newly Diagnosed Unfavourable Intermediate- to Very-high-risk Prostate Cancer: Results from a Phase 3, Prospective, Multicentre Study (LIGHTHOUSE). Eur Urol. 2023 Oct;84(4):361-370. doi: 10.1016/j.eururo.2023.06.018. Epub 2023 Jul 5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BED-PSMA-301
Identifier Type: -
Identifier Source: org_study_id
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