Using PYLARIFY PET imaging to detect prostate cancer in men with favorable intermediate risk

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

This study is testing if a special type of scan called PYLARIFY PET can help find prostate cancer that might have spread in men with a certain level of risk.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 274 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Lantheus Medical Imaging (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 14 sites (Birmingham, Alabama and 13 other locations)
• Trial ID: NCT06074510 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of PYLARIFY PET imaging in detecting prostate cancer that may have spread beyond the prostate gland in men diagnosed with favorable intermediate risk prostate cancer. Participants will receive a single dose of PYLARIFY followed by a PET/CT or PET/MRI scan to assess the presence of cancer. If the scan indicates potential cancer spread, further diagnostic tests or treatments may be recommended. The study will monitor participants for up to 12 months to gather data on their treatment outcomes and PSA levels.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with confirmed favorable intermediate risk prostate cancer.

Not a fit: Patients with high energy gamma-emitting radiation exposure or those not meeting the favorable intermediate risk criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of prostate cancer detection and inform treatment decisions for patients.

How similar studies have performed: Other studies using similar imaging techniques have shown promise in improving cancer detection, suggesting potential success for this approach.

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)

Where this trial is running

Birmingham, Alabama and 13 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• Hoag Cancer Center — Irvine, California, United States (Recruiting)
• Tower Urology — Los Angeles, California, United States (Recruiting)
• University of California San Francisco — San Francisco, California, United States (Recruiting)
• Emory University — Atlanta, Georgia, United States (Recruiting)
• University of Iowa Health Care — Iowa City, Iowa, United States (Recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Karmanos Cancer Institute Wayne State University — Detroit, Michigan, United States (Recruiting)
• BAMF Health — Grand Rapids, Michigan, United States (Recruiting)
• Washington University School of Medicine — St. Louis, Missouri, United States (Recruiting)
• Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
• Oregon Health & Science University — Portland, Oregon, United States (Recruiting)
• Huntsman Cancer Institute University of Utah — Salt Lake City, Utah, United States (Recruiting)

Study contacts

• Study coordinator: Senior Clinical Trial Manager

Conditions Prostate Cancer; Favorable Intermediate Risk; PYLARIFY; PET