This phase IV trial studies how well fluciclovine F18 positron emission tomography (PET)/computed tomography (CT) works in diagnosing cancer that has spread to the bone in patients with prostate cancer that is castration-resistant and has spread to other places in the body or has increasing prostate-specific antigen (PSA) following treatment. Fluciclovine F18 is a type of imaging agent, that when injected into the bloodstream, is taken up by prostate cancer cells. Using a PET/CT scan, doctors may be able to see the fluciclovine F18 and thus the cancer cells that have spread to the bone.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03496844.
PRIMARY OBJECTIVES:
I. Validation by core needle biopsy of suspected osseous metastases identified on fluciclovine F18 (F-18 fluciclovine)-PET/CT in patients with biochemical recurrence (BCR) with suspicious unconfirmed bone lesions (cohort 1) or patients with castrate resistant prostate cancer (CRPC) in need for biopsy for molecular testing (cohort 2).
SECONDARY OBJECTIVES:
I. Correlate the results of blood cell free deoxyribonucleic acid (DNA) mutational analysis, tissue mutational testing of the biopsy material, and results of the F-18 fluciclovine-PET/CT (standardized uptake value [SUV] of lesions and extent of disease). (Exploratory)
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients undergo standard of care bone biopsy.
COHORT II: Patients receive fluciclovine F18 intravenously (IV) and undergo PET/CT scan over 1-1.5 hours. Patients then undergo standard of care bone biopsy.
After completion of study, patients are followed up for at least 12 months.
Lead OrganizationBanner University Medical Center - Tucson
Principal InvestigatorPhillip Kuo
