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

Running, not enrolling · Phase 4

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID: NCT06074510
Run by: Lantheus Medical Imaging
People needed: 274
Starts: 2024-02-08
Expected to finish: 2026-09-01
Last updated by the study team: 2025-09-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Patients must have the ability to understand and sign an approved informed consent form (ICF)
Patients must have the ability to understand and comply with all protocol requirements
Patients must be ≥ 18 years of age
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Patients with life expectancy of at least 13 months as determined by the investigator
Patients must have confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate per 2023 NCCN guidelines. FIR risk group confirmation includes all the following:
1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL)
ISUP Grade Group 1 or 2
<50% biopsy cores positive (e.g., <6 of 12 cores)
Note: Date of the prostate biopsy should be no sooner that 2 weeks and no later than 3 months prior to PYLARIFY PET imaging

You may not qualify if…

Patients administered any high energy (>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging)
Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy
Known hypersensitivity to the components of PYLARIFY or its analogs
Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study
Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)

Where it is running

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

Full record on ClinicalTrials.gov

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