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PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer
Sponsor: Lantheus Medical Imaging
Summary
The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer. Participants will receive a single dose of PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan.
Official title: A Phase 4 Open-Label Multicenter Study of PYLARIFY® PET/CT or PET/MRI in Men With Newly Diagnosed Favorable Intermediate Risk (FIR) Prostate Cancer
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
274
Start Date
2024-02-08
Completion Date
2026-09
Last Updated
2025-09-11
Healthy Volunteers
No
Conditions
Interventions
Piflufolastat F 18 Intravenous Solution [PYLARIFY]
Participants will receive a single dose of 333 MBq (9 mCi) \[296 MBq-370 MBq (8 mCi - 10 mCi)\] PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours post-dosing
Locations (14)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Hoag Cancer Center
Irvine, California, United States
Tower Urology
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
University of Iowa Health Care
Iowa City, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute Wayne State University
Detroit, Michigan, United States
BAMF Health
Grand Rapids, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Huntsman Cancer Institute University of Utah
Salt Lake City, Utah, United States