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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Piflufolastat F 18 Intravenous Solution [PYLARIFY]

• Study Type: Interventional
• Enrollment (Estimated): 274
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
  • California
    • Irvine, California, United States, 92618
      • Hoag Cancer Center
    • Los Angeles, California, United States, 90048
      • Tower Urology
    • San Francisco, California, United States, 94158
      • University of California San Francisco
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Health Care
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute Wayne State University
    • Grand Rapids, Michigan, United States, 49503
      • BAMF Health
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PYLARIFY PET	Drug: 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; Other Names: PYLARIFY; 18F-DCFPyL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in intended patient clinical management	Intended medical management plan before and after PYLARIFY PET imaging	Day 30
True detection rate	The percentage of participants with at least one true positive lesion identified on PYLARIFY PET imaging and confirmed by the truth standard. This measure includes patients in whom PYLARIFY PET detected previously occult intraprostatic ISUP grade ≥3 lesions as confirmed by pathology; or patients in whom PYLARIFY PET detected the presence of either/or extraprostatic extension, seminal vesicle invasion, regional lymph node involvement, distant metastases as assessed by central readers and verified by the standard of truth.	Day 1
Correct localization rate	The percentage of participants for whom there is a one-to-one correspondence on the same side between the location of at least one lesion outside of prostate capsule (extraprostatic extension, seminal vesicle invasion, pelvic lymph nodes, extrapelvic lymph nodes, extrapelvic bone or extrapelvic soft tissue lesion(s) identified on PYLARIFY PET/CT or PET/MR and the standard of truth.	up to day 90
Positive predictive value of PYLARIFY	The percentage of participants who undergo PYLARIFY PET imaging that identifies a lesion or lesions outside of the prostate capsule and have an established standard of truth. Positive predictive value does not require a one-to-one correspondence by lesion location but requires that the lesion and standard of truth be within the same anatomic region, including prostatic, pelvic, extra-pelvic or distant lesions.	up to day 90
Sensitivity of PYLARIFY	Sensitivity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.	up to day 90
Specificity of PYLARIFY	Specificity at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.	up to day 90
Negative predictive value of PYLARIFY	Negative predictive value at the patient level for patients who undergo prostate surgery for prostate and with pelvic lymph nodes removal.	up to day 90
Number of participants with Adverse Events		Day 1

Collaborators and Investigators

• Sponsor: Lantheus Medical Imaging

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: PET; Prostate Cancer; Favorable Intermediate Risk; PYLARIFY
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid
• Other Study ID Numbers: PYL4301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No