Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06074510 | RECRUITING | Prostate Cancer

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

Lantheus Medical Imaging

Brief 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.

Condition or disease

Prostate Cancer

Intervention/treatment

Piflufolastat F 18 Intravenous Solution [PYLARIFY]

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 274 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
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
Actual Study Start Date : 2024-02-08
Estimated Primary Completion Date : 2026-11
Estimated Study Completion Date : 2026-11

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
Inclusion 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)
    • Note: Date of the prostate biopsy should be no sooner that 2 weeks and no later than 3 months prior to PYLARIFY PET imaging
    Exclusion Criteria
    • 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)
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer

Location Details

NCT06074510

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35249

RECRUITING

United States, California

Hoag Cancer Center

Irvine, California, United States, 92618

RECRUITING

United States, California

Tower Urology

Los Angeles, California, United States, 90048

RECRUITING

United States, California

University of California San Francisco

San Francisco, California, United States, 94158

RECRUITING

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Iowa

University of Iowa Health Care

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Maryland

Johns Hopkins University

Baltimore, Maryland, United States, 21205

RECRUITING

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Road cancer

Karmanos Cancer Institute Wayne State University

Detroit, Road cancer, United States, 48201

RECRUITING

United States, Road cancer

BAMF Health

Grand Rapids, Road cancer, United States, 49503

RECRUITING

United States, Missouri

Washington University School of Medicine

St. Louis, Missouri, United States, 63110

RECRUITING

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

RECRUITING

United States, Oregon

Oregon Health & Science University

Portland, Oregon, United States, 97239

RECRUITING

United States, Utah

Huntsman Cancer Institute University of Utah

Salt Lake City, Utah, United States, 84112