Fluciclovine F18 PET / CT in Diagnosing Bone Metastases in Patients with Metastatic Castration-Resistant or Biochemically Recurrent Prostate Cancer
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.
- COHORT I:
- Prostate cancer (PC) patients who have had an F-18 fluciclovine-PET/CT scan for routine standard of care for biochemical recurrence
- Need for a standard of care bone biopsy
- COHORT II:
- Prostate cancer patients who would not ordinarily obtain an Axumin-PET scan for routine standard of care but have a need for bone biopsy
- Patients with metastatic castrate resistant prostate cancer
Locations & Contacts
Contact: Phillip Kuo
Trial Objectives and Outline
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).
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.
Trial Phase & Type
Banner University Medical Center - Tucson
Secondary IDs NCI-2019-01533
Clinicaltrials.gov ID NCT03496844