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

NCT06074510 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: PYL4301
• Study Type: interventional
• Target: 274
• Locations: 1 country
• Sites: 14

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

Keywords

Prostate Cancer; Favorable Intermediate Risk; PYLARIFY; PET

Outcome Measures

Primary Outcomes (1)

• Detection rate

  The proportion of participants with prostate cancer in whom PYLARIFY PET detected previously occult intraprostatic ISUP grade ≥3 lesions as assessed by pathology, or in whom PYLARIFY PET detected the presence of either/or extraprostatic extension, seminal vesicle invasion, regional lymph node involvement, distant metastases, divided by the number of subjects who undergo a PYLARIFY PET scan

  Day 1

Secondary Outcomes (8)

• Change in intended patient clinical management

  Day 30

• True detection rate

  Day 1

• Correct localization rate

  up to day 90

• Positive predictive value of PYLARIFY

  up to day 90

• Sensitivity of PYLARIFY

  up to day 90

Study Arms (1)

PYLARIFY PET

EXPERIMENTAL

Drug: Piflufolastat F 18 Intravenous Solution [PYLARIFY]

Interventions

Piflufolastat F 18 Intravenous Solution [PYLARIFY] 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

Also known as: PYLARIFY, 18F-DCFPyL

PYLARIFY PET

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:
• 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)

Sponsors & Collaborators

• Lantheus Medical Imaging: lead

Study Sites (14)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Hoag Cancer Center

Irvine, California, 92618, United States

Location

Tower Urology

Los Angeles, California, 90048, United States

Location

University of California San Francisco

San Francisco, California, 94158, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Karmanos Cancer Institute Wayne State University

Detroit, Michigan, 48201, United States

Location

BAMF Health

Grand Rapids, Michigan, 49503, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Huntsman Cancer Institute University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start: February 8, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

US (14)