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

Open to males ages 18 years and up

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

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)