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

Description

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.

Conditions

Prostate Cancer

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35249

Irvine

Hoag Cancer Center, Irvine, California, United States, 92618

Los Angeles

Tower Urology, Los Angeles, California, United States, 90048

San Francisco

University of California San Francisco, San Francisco, California, United States, 94158

Baltimore

Johns Hopkins University, Baltimore, Maryland, United States, 21205

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Detroit

Karmanos Cancer Institute Wayne State University, Detroit, Michigan, United States, 48201

Grand Rapids

BAMF Health, Grand Rapids, Michigan, United States, 49503

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Salt Lake City

Huntsman Cancer Institute University of Utah, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patients must have the ability to understand and sign an approved informed consent form (ICF)
  • 2. Patients must have the ability to understand and comply with all protocol requirements
  • 3. Patients must be ≥ 18 years of age
  • 4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • 5. Patients with life expectancy of at least 13 months as determined by the investigator
  • 6. 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)
  • 1. Patients administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging)
  • 2. Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy
  • 3. Known hypersensitivity to the components of PYLARIFY or its analogs
  • 4. 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
  • 5. Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Lantheus Medical Imaging,

Study Record Dates

2026-01