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

NCT ID: NCT06074510

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 274 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-08
• Study Completion Date: 2026-09-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PYLARIFY PET

Group Type: EXPERIMENTAL

Piflufolastat F 18 Intravenous Solution [PYLARIFY]

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Other Intervention Names

PYLARIFY; 18F-DCFPyL

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Lantheus Medical Imaging

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

PYL4301

Identifier Type: -

Identifier Source: org_study_id