Validation of FACBC for Detection of Metastasis Among High-risk Prostate Cancer Patients With Presumed Localized Disease

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

This study is for patients who have a high risk of metastatic prostate cancer (cancer that has spread outside of the prostate) who are going to have radical prostatectomy. The Anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC or Fluciclovine) positron emission tomography (PET) scan is a new imaging approach that has promising results in showing progression of cancer. The goal of this study is to determine if FACBC PET imaging will detect metastatic disease in patients with high risk prostate cancer who have negative conventional cross-sectional imaging such as computed tomography (CT) and/or magnetic resonance imaging (MRI), as well as bone scan and/or sodium fluoride PET. FACBC PET imaging may help detect metastatic prostate cancer in patients with newly diagnosed high risk primary prostate cancer and potentially improve staging of the cancer. Additionally, the researchers will compare the FACBC uptake in the prostate with uptake of FACBC detected in metastasis. They will also analyze and compare the prostate tissue, serum and urine parameters that are linked to higher rates of FACBC positivity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• High-risk prostate cancer patients eligible for standard of care surgery

• At least clinical T3a disease, and/or Gleason≥8, and/or Prostate-Specific Antigen (PSA) >20, as per clinical assessment and routine guidelines

• Undergone standard of care conventional imaging (CT and/or MRI; bone scan and/or sodium fluoride (NaF) PET)

Exclusion Criteria:

• Definitive findings of systemic metastasis on conventional imaging.