Fluorine F 18 Sodium Fluoride PET/CT and Whole Body and Axial MRI in Finding Metastases in Patients With Recurrent Prostate Cancer

PRIMARY OBJECTIVES:

I. To determine the proportion of patients with biochemically-recurrent prostate cancer (PC)
in whom imaging with whole body (WB)/axial MRI and F-18 NaF (fluorine F 18 sodium fluoride)
PET/CT results in detection of metastatic disease not visualized on CT scan and bone scan.

SECONDARY OBJECTIVES:

I. To estimate the percent of eligible patients with negative, indeterminate and positive CT
scan/bone scan and targeted X-rays if done.

II. To determine the proportion of patients with biochemically-recurrent PC in whom
recurrence in the prostate bed can be visualized using MRI in the absence of detection using
CT scan.

III. To correlate the presence of metastatic disease detected using WB/axial MRI and/or F-18
NaF PET/CT with the predicted 6-year probability of progression-free survival based on the
Memorial Sloan Kettering Cancer Center salvage radiation therapy (RT) PC nomogram, and with
prostate-specific antigen (PSA) level at baseline.

IV. To compare the role of axial MRI of the spine to WB/axial MRI with respect to their
ability to identify sites of disease. Similarly, to evaluate the relative contribution of
F-18 NaF PET and WB/axial MRI.

OUTLINE:

Patients first undergo CT scan and bone scan. Patients with negative results from the CT and
bone scans then undergo WB MRI scan using diffusion-weighted MRI, axial MRI scan using
3-Tesla MRI, and fluorine F 18 sodium fluoride PET/CT scan.

After completion of study, patients are followed up at 4-6 months and periodically until week
52.

Inclusion Criteria:

- History of prior radical prostatectomy for prostate cancer

- Two PSA values >= 0.2 ng/mL at least 4 weeks after prostatectomy

- Patients who have started radiographic evaluation and underwent CT scan and/or bone
scan prior to registration to the study will be able to participate under a late
registration provision, provided that the more modern scans (WB/axial MRI and F-18 NaF
PET/CT) can be completed within 8 weeks after CT scan and bone scan

Exclusion Criteria:

- Patients with known metastatic disease

- PSA recurrence not verified by elevated PSA as discussed in the eligibility section

- Patients who initiated androgen deprivation therapy or other systemic therapy
(chemotherapy, immunotherapy, targeted therapy) for PSA recurrence; nutritional
supplements used for treatment of PSA recurrence will be allowed