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ACTIVE NOT RECRUITING
NCT06074510
PHASE4

PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer

Sponsor: Lantheus Medical Imaging

View on ClinicalTrials.gov

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

DRUG

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