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

Launched by LANTHEUS MEDICAL IMAGING · Oct 3, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging method called PYLARIFY PET to see if it can safely and accurately find prostate cancer that may have spread beyond the prostate gland in men with a specific type of prostate cancer known as favorable intermediate risk (FIR). If you are a man aged 18 or older with confirmed FIR prostate cancer and meet certain health criteria, you might be eligible to participate.

If you join the study, you will receive an injection of PYLARIFY, and then you will have a whole-body scan about 1 to 2 hours later. This scan will help doctors see if there are any signs of cancer outside the prostate. If the scan shows something suspicious, you may need additional tests or treatments within a few months. Throughout the study, your health will be monitored for up to 12 months, including regular blood tests for prostate-specific antigen (PSA) levels, which help track your prostate health. This trial could help improve how doctors diagnose and treat prostate cancer in the future.

Gender

MALE

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)