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, and
semi-quantitative uptake on technetium tc-99m medronate (99mTc-MDP) bone scintigraphy and
(18F) fluciclovine- PET/CT at baseline.

III. Determine the correlation between the number of lesions, their visual uptake, and
semi-quantitative uptake on 99mTc-MDP bone scintigraphy and (18F) fluciclovine- PET/CT after
3 and 6 cycles of treatment.

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, 3 months and at approximately 6 months of radium-223 therapy.

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

Inclusion Criteria:

- Enrollment on IRB #102312 (A Phase 2 Study of Radium-223 and Radiotherapy in
Hormone-Naive Men with Oligometastatic Prostate Cancer to Bone).

- Patients must document their willingness to be followed for up to 24 months after
recruitment by signing informed consent documenting their agreement to allow access to
the data obtained on IRB #102312 and information and data entered into a research
database.

- All patients, or their legal guardians, must sign a written informed consent and
Health Insurance Portability and Accountability Act (HIPAA) authorization in
accordance with institutional guidelines.

Exclusion Criteria:

- Patients with known allergic or hypersensitivity reactions to previously administered
radiopharmaceuticals. Patients with significant drug or other allergies or autoimmune
diseases may be enrolled at the Investigator?s discretion.

- Patients who require monitored anesthesia for PET scanning.

- Patients who are too claustrophobic to undergo PET scanning.