Prostate Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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).

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

391

Study ID:

NCT04186845

Recruitment Status:

Completed

Sponsor:

Blue Earth Diagnostics

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There are 28 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
Tower Urology
Los Angeles California, 90048, United States
University of California Irvine Medical Center (UCIMC)
Orange California, 92868, United States
John Wayne Cancer Institute
Santa Monica California, 90403, United States
Emory University Hospital
Atlanta Georgia, 30322, United States
Northside Hospital
Austell Georgia, 30342, United States
Northshore University HealthSystem
Evanston Illinois, 60201, United States
Loyola University Medical Center
Maywood Illinois, 60153, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University
Baltimore Maryland, 21287, United States
Chesapeake Urology Research Associates
Towson Maryland, 21204, United States
University of Michigan Ann Arbor
Ann Arbor Michigan, 48109, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Montefiore Hospital
Bronx New York, 10461, United States
Queens Hospital Center (QHC - Queens Cancer Center
Jamaica New York, 11432, United States
Mount Sinai Faculty Practice Associates
New York New York, 10029, United States
Stony Brook University
Stony Brook New York, 11794, United States
Duke University Medical Center
Durham North Carolina, 27701, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
MidLantic Urology
Philadelphia Pennsylvania, 19004, United States
MD Anderson Hospital
Houston Texas, 77054, United States
Urology San Antonio
San Antonio Texas, 78229, United States
University of Virginia - Health Science Center
Charlottesville Virginia, 22908, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
Turku University Hospital
Turku , FI-20, Finland
CWZ
Nijmegen , 6532, Netherlands
Maxima MC
Veldhoven , 5504 , Netherlands

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

391

Study ID:

NCT04186845

Recruitment Status:

Completed

Sponsor:


Blue Earth Diagnostics

How clear is this clinincal trial information?

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