Fluciclovine F18 PET/CT Imaging in Assessing Hormone-Naive Men with Prostate Cancer that has Spread to the Bone

PRIMARY OBJECTIVES:

I. Abnormal fluciclovine F18 ([18F] fluciclovine) uptake on visual assessment will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

II. Maximum standardized uptake value (SUVmax) and mean standardized uptake value (SUVmean) on (18F) fluciclovine-positron emission tomography (PET)/computed tomography (CT) imaging will differ by the type of metastatic lesion present (blastic, lytic, marrow, mixed).

SECONDARY OBJECTIVES:

I. Determine if a 25% or greater reduction in average (ave)SUVmax or aveSUVmean on (18F) fluciclovine-PET/CT imaging after completion of all radiation therapy will be predictive of increased time to biochemical failure.

II. Determine the correlation between the number of lesions, their visual uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and visual lesion number and uptake with (18F) fluciclovine- PET/CT at baseline in subjects with known bone metastases in an androgen-sensitive prostate cancer disease phase.

III. Determine the correlation between the number of lesions, their visual uptake on 99mTc-MDP bone scintigraphy and visual lesion number and uptake with (18F) fluciclovine- PET/CT after 3 and 6 cycles of radium 223 infusion and stereotactic ablation of oligometastatic bone tumors.

OUTLINE: This is a companion imaging study to Institutional Review Board (IRB) #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).

Patients receive fluciclovine F18 intravenously (IV) over 30 seconds and undergo PET/CT scan over 60 minutes at baseline, between 3 and 4 months and at approximately 6-7 months of radium-223 therapy.

After completion of diagnostic testing, patients are followed for 2 years.