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

Lantheus Medical Imaging

Status and phase: Enrolling; Phase 4

Conditions: Prostate Cancer

Treatments: Drug: Piflufolastat F 18 Intravenous Solution [PYLARIFY]

Study type: Interventional

Funder types: Industry

Identifiers

NCT06074510

PYL4301

Details and patient eligibility

About

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.

Enrollment: 274 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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274 participants in 1 patient group

PYLARIFY PET

Experimental group

Treatment:

Drug: Piflufolastat F 18 Intravenous Solution [PYLARIFY]